FIELD CORRECTIVE ACTION LISTING FOR AUGUST 2023
The list below contains Medical Device’s Field Corrective Action for the month of August 2023. This list provides field corrective action reporting information to MDA by establishment in accordance to requirement stipulated in Section 41, Act 737 and Regulation 6 of Medical Device (Duties and Obligations of Establishment) Regulations 2019.
Field Corrective Action (FCA) is part of a post-marketing risk assessment measure to ensure the continued safe use of medical devices in the Malaysia market. It is a corrective or preventive action in relation to a medical device which may include –
(a) The return of the medical device to the establishment;
(b) Modification of the medical device;
(c) Exchange of the medical device;
(d) Destruction of medical device; or
(e) Specific advice on the use of the medical device.
If you have experienced any safety and performance issue with one of the medical devices listed for FCA action, please seek advice from your medical device authorised representative as soon as possible.
|
Date received |
Title of FCA |
Affected Medical Device |
MDA Reference Number |
MDA Registration Number |
Description |
Local Establishment Contact Detail |
|
17 Aug 2023 |
NGQ Device Bluetooth Malfunction Field Safety Corrective Action (FA-Q122-CRM-2) |
Abbott NGQ Implantable Pulse Generators (IPG) And Patient Mobile Application (Gallant, Entrant, And Mymerlinpulse) |
MDA/FCA/P0477-82744691-2023 |
GD9675621-53441 |
Abbott is informing customers of a rare potential for a Bluetooth (BLE) circuit component issue on a subset of Gallant™ and Entrant™ Implantable Cardioverter Defibrillators (ICDs) and Cardiac Resynchronization Therapy Defibrillators (CRT-Ds) manufactured prior to April 2022. |
LAW CHING YEE REGULATORY AFFAIRS MANAGER ABBOTT MEDICAL (MALAYSIA) SDN. BHD. |
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25 Aug 2023 |
Apical Coring Knife Unable to Cut Field Safety Corrective Action (FA-Q323-HF-3) |
HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM |
MDA/FCA/P0491-93120126-2023 |
GD4151721-74880 |
Abbott is notifying customers of a finding with the HeartMate Apical Coring Knife provided with the HeartMate 3 Left Ventricular Assist System (LVAS) kits (Model 106524INT) and the Apical Coring Knife (Model 1050) separately distributed for use during HeartMate 3 or HeartMate II LVAS (Model 106015 and 106016) implant procedures. |
LAW CHING YEE REGULATORY AFFAIRS MANAGER ABBOTT MEDICAL (MALAYSIA) SDN. BHD. |
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25 Aug 2023 |
Architect i1000sr Processing Module |
MDA/FCA/PX0500-94940230-2023 |
IVDA3676020-43793 |
ARCHITECT Software versions 9.45 (LNs 05F48‐44 and 05F48‐45) and 9.50 (LNs 05F48‐46 and 05F48‐47) were developed to address several identified issues and enhance the overall system for the ARCHITECT C‐Systems (CC) and ARCHITECT i‐Systems (IA). |
LAW CHING YEE REGULATORY AFFAIRS MANAGER ABBOTT MEDICAL (MALAYSIA) SDN. BHD. |
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4 Aug 2023 |
CONSTELLATION VISION SYSTEM |
MDA/FCA/P0435-44724282-2023 |
GC96073327017 |
Alcon has become aware of the potential for the plastic wrench included with phaco tips to be damaged if over-tightened. |
LEW FOO YEW DIRECTOR ALCON LABORATORIES (M) SDN. BHD. |
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18 Aug 2023 |
CENTURION VISION SYSTEM |
MDA/FCA/P0444-60741868-2023 |
GC33225370917 |
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7 Aug 2023 |
CENTURION SILVER SYSTEM |
MDA/FCA/P0445-92789087-2023 |
GC64723659618 |
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18 Aug 2023 |
LAUREATE WORLD PHACO SYSTEM |
MDA/FCA/P0447-46986377-2023 |
GC86958174517 |
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18 Aug 2023 |
INFINITI VISION SYSTEM |
MDA/FCA/P0448-12989409-2023 |
GC31512297417 |
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7 Aug 2023 |
LEGION SYSTEM |
MDA/FCA/P0449-89178457-2023 |
GC9676720-46802 |
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7 Aug 2023 |
CUSTOM PAK: MAL-PCMC INTREPID PACK (PRINCE COURT MEDICAL CTR) |
MDA/FCA/P0450-27674265-2023 |
GB973251049518 |
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7 Aug 2023 |
CUSTOM PAK: MAL-HOSPITAL PANTAI BATU PAHAT PHACO PACK |
MDA/FCA/P0451-79118574-2023 |
GB3395423-128359 |
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28 Aug 2023 |
FSCA-2023-08-14 (1) / Infusomat® Space - Upstream Occlusion Sensor |
INFUSION PUMP |
MDA/FCA/P0486-19645440-2023 |
GC92724141717 |
B Braun identified a sporadic occurrence of potentially false down- and upstream pressure alarms which are caused by the upstream occlusion pressure sensor of the Infusomat® Space Infusion Pump. |
QUEK LANG FAH HEAD OF REGULATORY AFFAIRS B. BRAUN MEDICAL INDUSTRIES SDN. BHD. |
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22 Aug 2023 |
ISE REAGENTS AND STANDARDS |
MDA/FCA/P0482-74114323-2023 |
IVDB56688175918 |
Beckman Coulter has identified that the defective K electrode (Lot 22303 and serial numbers listed in the table above) may not perform as intended through the expiration date. |
NUR AISHAH BINTI ABD AZIZ RA SPECIALIST BECKMAN COULTER MALAYSIA SDN. BHD. |
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22 Aug 2023 |
ACCESS IL-6 |
MDA/FCA/P0482-82078148-2023 |
IVDB2507021-52609 |
BEC Chaska Incoming Inspection identified that the part numbers C33377 and 02-006988A failed the XRF (X-Ray Fluoroscopy) tests for high cadmium levels. Per RoHS3 EU Directive 2015/863, the cadmium values should be less than 100 PPM (parts per million). The failed parts had an average cadmium reading of 236 PPM for P/N C33377 and average reading of 111 PPM for P/N 02-006988A using XRF. Post inspection, a sorting was conducted between Jun 15, 2023 and Jun 20, 2023 in Building 316 on all available inventory on hand and all parts are discovered to be non-compliant to the RoHS3 Directive. |
NUR AISHAH BINTI ABD AZIZ RA SPECIALIST BECKMAN COULTER MALAYSIA SDN. BHD. |
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9 Aug 2023 |
DAKO HISTOLOGY/ CYTOLOGY HISTOLOGY/ CYTOLOGY REAGENTS CLUSTER 2 |
MDA/FCA/P0454-92274525-2023 |
IVDB83493297718 |
Based on investigation and attention, the GV800 Kits is facing certain cases where an increase in debris formation on the stainer gap lids in the Dako Omnis is observed which can lead to an increased level of artefacts and background staining on the stained slides. |
HOW KIAN MING MANAGING DIRECTOR BITA LIFESCIENCE SDN. BHD. |
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15 Aug 2023 |
FSCA-SHS-2023-001, OPMI LUMERA 300, inspect (repair if needed) the suspension arm |
OPMI LUMERA 300 |
MDA/FCA/P0466-98412586-2023 |
GA1921556216 |
There is a probability of specific screw missing during assembly of the device. This screw is used to prevent one internal thread cap rotating which ensure the connection between suspension arm and the suspended components. |
YAP CHUN CHONG GENERAL MANAGER CARL ZEISS SDN BHD |
|
28 Aug 2023 |
Revision on stability claim in the STORAGE AND STABILITY in Insert - Liquichek Pediatric Control |
LIQUICHEK PEDIATRIC CONTROL |
MDA/FCA/P0445-69893092-2023 |
IVDC8942823-127545 |
Bio-Rad have observed that Bilirubin (Total, Direct, Indirect and Neonatal) and Phenylalanine may not meet the Thawed Unopened stability; or the Thawed Open Stability clams for Bilirubin (Total, Direct, Indirect and Neonatal) as printed in the package inserts. |
ADELINE NG POOI KUAN GROUP CORPORATE COMPLIANCE SENIOR MANAGER CHEMOPHARM SDN BHD |
|
3 Aug 2023 |
FABIUS FAMILY |
MDA/FCA/P0442-88055199-2023 |
GC52775717518 |
Feedback from the market has shown that condensate can form more frequently in our TwinStar Plus filter/HME, which can lead to increased resistance under certain circumstances. |
BEATRICE MAH WAN XIN QUALITY AND REGULATORY AFFAIR SPECIALIST DRAEGER MALAYSIA SDN BHD |
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3 Aug 2023 |
DRAEGER BABYROO TN300 |
MDA/FCA/P0443-69935471-2023 |
GC10992123-134656 |
Drager has become aware that the TN300 Babyroo Radiant Warmer mattress tray may tilt without engaging the tilt mechanism when the mattress assembly is pushed down. The tilt mechanism may not lock/release correctly due to either loose or missing screws. |
BEATRICE MAH WAN XIN QUALITY AND REGULATORY AFFAIR SPECIALIST DRAEGER MALAYSIA SDN BHD |
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18 Aug 2023 |
AmiCORE Apheresis System |
MDA/FCA/P0478-10472352-2023 |
GC2949119-28560 |
it was discovered that two AmiCORE Apheresis Kits were assembled incorrectly. The saline and return lines were swapped at the connection to the AmiCORE Cassette. |
FOO AI LIN HEAD, SCIENTIFIC AND REGULATORY AFFAIRS FRESENIUS KABI MALAYSIA SDN BHD |
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17 Aug 2023 |
VIVID S SERIES (S60N, S70N) |
MDA/FCA/P0393-17367616-2023 |
GB48228729218 |
GE HealthCare has become aware that certain Vivid ultrasound systems may not boot up in a timely fashion. If this occurs, it can delay availability of the device in time-critical emergency situations. |
LIM SOCK SIANG DIRECTOR GE HEALTHCARE SDN. BHD |
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28 Aug 2023 |
Centricity™ Enterprise Archive V2.X, V3.X, V4.X and Enterprise Archive Version 8 GE HealthCare has become aware of an issue where images from two different patients may be contained in a single study, when stored in Centricity Enterprise Archive (EA) and/or Enterprise Archive (EA).
|
CENTRICITY ENTERPRISE ARCHIVE |
MDA/FCA/P0501-63360510-2023 |
GMD96569988219A |
GE HealthCare has become aware of an issue where images from two different patients may be contained in a single study, when stored in Centricity Enterprise Archive (EA) and/or Enterprise Archive (EA). This issue could contribute to an adverse patient outcome. |
LIM SOCK SIANG DIRECTOR GE HEALTHCARE SDN. BHD |
|
26 Aug 2023 |
[CVG-21-Q3-21 Rev Q] HVAD Pump Failure to Restart: Additional Subgroup 3 and Updated Failure Rate |
HEARTWARE VENTRICULAR ASSIST SYSTEM (HVAD) |
MDA/FCA/P0499-62484340-2023 |
GD74345985518 |
Complaints received on pumps failing to initially start, restart or experiencing a delay in restart within the maximum number of restart attempts per the software configuration (30 restart attempts), regardless of whether the pump ultimately restarted. These failures to start or restart have occurred during pre-implant testing, during the implant, or in a variety of post-implant situations. Failures include both single and dual-stator pump restart failures. |
CHOW SOON YEE REGULATORY AFFAIRS LEAD MEDTRONIC MALAYSIA SDN BHD |
|
30 Aug 2023 |
Ultrasound gel and ecg gel was reported contamination of bacteria Burkholderia Cepacia. |
TRANSMISSION GEL |
MDA/FCA/P0119-22257574-2022 |
GA13780404317 |
MyMedic had used RO Water System that will reduces particles like dirt, dust and rust, volatile organic compounds (VOCs), chlorine, other contaminants that give water a bad taste or odor and it removes up to 98% of total dissolved solids. Even so, upon arisal of the contamination issue |
MOHAMAD FARKHAN BIN DAMRI ASST MANAGER MYMEDIC INNOVATION SDN BHD |
|
28 Aug 2023 |
VISERA VIDEOSCOPES SYSTEM |
MDA/FCA/P0462-37315314-2023 |
GB757621017518 |
This Field Safety Notice is initiated based on the complaint investigation reported outside Malaysia (Foreign Country) which associated with an injury, that upon trying to use an Olympus pulmonary endoscope model with an endotracheal tube, the tip became lodged inside the endotracheal tube connector. |
YEOH SEO CHING, SHELLY MANAGER, QUALITY ASSURANCE & REGULATORY AFFAIRS OLYMPUS (MALAYSIA) SDN. BHD. |
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EVIS LUCERA ELITE BRONCHOVIDEOSCOPE SYSTEM |
MDA/FCA/P0468-48608010-2023 |
GB66358142517 |
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EVIS EXERA II BRONCHOVIDEOSCOPE |
MDA/FCA/P0469-56641384-2023 |
GB97717930218 |
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EVIS EXERA III BRONCHOVIDEOSCOPE SYSTEM |
MDA/FCA/P0470-36592475-2023 |
GB58878308917 |
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OPTERA VIDEO SYSTEM |
MDA/FCA/P0472-19146910-2023 |
GB15542818418 |
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EUS ULTRASONIC VIDEOSCOPE SYSTEM |
MDA/FCA/P0475-98174303-2023 |
GB79514818718 |
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EVIS EUS ULTRASOUND BRONCHOFIBERVIDEOSCOPE |
MDA/FCA/P0476-98443677-2023 |
GB2370620-43094 |
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RESECTOSCOPE SYSTEM |
MDA/FCA/P0502-42998716-2023 |
GC75601857218 |
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30 Aug 2023 |
CYSTOSCOPE SYSTEM |
MDA/FCA/P0504-24421187-2023 |
GC624861210918 |
This field safety notice is initiated to notify customers that certain products of Olympus bear an incorrectly printed GTIN (13-digit GTIN-14 instead of the standard 14 digits.). |
YEOH SEO CHING, SHELLY MANAGER, QUALITY ASSURANCE & REGULATORY AFFAIRS OLYMPUS (MALAYSIA) SDN. BHD. |
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9 Aug 2023 |
ALLURA CENTRON |
MDA/FCA/P0453-71370964-2023 |
GC67062225117 |
The wired and wireless foot switch are used to control fluoroscopy, exposure and other functions, such as single shot, light control and toggle between X-ray planes (for bi-plane systems). |
ZAM ZARINA BINTI MAT AIL Q&R MANAGER PHILIPS MALAYSIA SDN BERHAD |
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ALLURA XPER FD SERIES |
MDA/FCA/P0456-73809169-2023 |
GC59365128817 |
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AZURION 3 |
MDA/FCA/P0457-45965313-2023 |
GC99381544218 |
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AZURION 5 |
MDA/FCA/P0458-51798714-2023 |
GC10785320-48186 |
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AZURION 7 |
MDA/FCA/P0459-96354025-2023 |
GC82521235717 |
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AZURION BIPLANE |
MDA/FCA/P0460-98786232-2023 |
GC59959884718 |
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23 Aug 2023 |
2023-CC-EC-005 Tempus Pro Monitor Unexpected Device Error When Used with Tempus Pro Video Laryngoscope
|
TEMPUS PRO |
MDA/FCA/P0485-49788517-2023 |
GC7494619-30213 |
An issue has been identified with the Tempus Pro Monitor where an error may occur during video laryngoscope use with the Tempus Pro Video Laryngoscope or immediately after the Tempus Pro Video Laryngoscope has been unplugged from the Tempus Pro Monitor. |
ZAM ZARINA BINTI MAT AIL Q&R MANAGER PHILIPS MALAYSIA SDN BERHAD |
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24 Aug 2023 |
ALLURA XPER FD SERIES |
MDA/FCA/P0487-35152266-2023 |
GC59365128817 |
The wired foot switch is used to control fluoroscopy, exposure, and other functions, such as single shot, light control, and toggle between X-ray planes (for bi-plane systems). Philips has identified instances where no or only intermittent X-ray radiation initiation is possible through use of the wired foot switch, as a result of: • A damaged foot switch cable or cable connector caused by large external force on the cable. |
ZAM ZARINA BINTI MAT AIL Q&R MANAGER PHILIPS MALAYSIA SDN BERHAD |
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ALLURA CENTRON |
MDA/FCA/P0489-97595069-2023 |
GC67062225117 |
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AZURION 3 |
MDA/FCA/P0490-88588253-2023 |
GC99381544218 |
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AZURION 5 |
MDA/FCA/P0492-36845833-2023 |
GC10785320-48186 |
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AZURION 7 |
MDA/FCA/P0493-40795912-2023 |
GC82521235717 |
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AZURION BIPLANE |
MDA/FCA/P0494-50290978-2023 |
GC59959884718 |
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30 Aug 2023 |
IRON_2 (IRON_2) |
MDA/FCA/P0460-14180898-2023 |
IVDB4921625717 |
Siemens received complaints from one customer indicating some wedges of IRON_2 Lot 601757 and 612584 exhibited a positive bias with Quality Control (QC) and patient samples processed on ADVIA Chemistry XPT systems. |
LAM YEN LI HEAD OF QUALITY & TECHNOLOGY SIEMENS HEALTHCARE SDN. BHD. |
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10 Aug 2023 |
Field Safety Corrective Action - Redwood Diagnostic Ultrasound Device |
ACUSON REDWOOD DIAGNOSTIC ULTRASOUND SYSTEM |
MDA/FCA/P0463-86529042-2023 |
GB9532820-39373 |
If user-generated presets on 18L6 transducers are carried-over from an ACUSON Redwood 1.0 system to an ACUSON Redwood 2.0 system, the ACUSON Redwood 2.0 system will display underestimated measurement results when using an 18L6 transducer and viewing in the Dual format (side by side) visualization function. |
LAM YEN LI HEAD OF QUALITY & TECHNOLOGY SIEMENS HEALTHCARE SDN. BHD. |
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15 Aug 2023 |
049 CN Kova POC 23-017 Chek-Stix Liquid QC + Sediment Incorrect Value Assignment for RBC and WBC |
ATELLICA UAS 800 ANALYZER |
MDA/FCA/P0472-93793337-2023 |
IVDB43102172618 |
Siemens Healthineers received a Field Action Notice from Kova International regarding incorrect value assignment for RBC and WBC on Quality Control (QC) level 2 for Chek-Stix Liquid QC + Sediment. |
LAM YEN LI HEAD OF QUALITY & TECHNOLOGY SIEMENS HEALTHCARE SDN. BHD. |
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24 Aug 2023 |
MR072/23/S Potential image artifacts caused by over-ear headphones - MAGNETOM Aera |
MAGNETOM AERA |
MDA/FCA/P0495-82465816-2023 |
GB29763244417 |
In some cases, when lubricating grease is present within the headband of the over-ear headphones, it may cause visible, dot- or line-shaped, fat-isointense artifacts during head examinations only. These potential artifacts depend on the position of the headband, the amount of lubricating grease, as well as the sequence parameters used. This issue does not impact scans of other body regions. |
LAM YEN LI HEAD OF QUALITY & TECHNOLOGY SIEMENS HEALTHCARE SDN. BHD. |
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3 Aug 2023 |
MEDICAL VENTILATOR |
MDA/FCA/P0441-98302024-2023 |
GC25545945118 |
A degrading capacitor on the control board might leak electrolyte onto the control board, causing a short circuit on the board and/or the capacitor might lose its function. The primary function of this capacitor is to provide energy to store “Realtime Clock” information in case of total loss of power (external AC supply and battery) for example during storage. |
NUR DIANA ABD RAZAK HEAD OF QUALITY ASSURANCE STAR MEDIK SDN BHD |
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17 Aug 2023 |
Serfas Probe Connection Issues with SERFAS Energy Generator Console |
STRYKER CROSSFIRE INTEGRATED ARTHROSCOPY SYSTEM |
MDA/FCA/P0016-12093644-2022 |
GC10496622-102855 |
Supply constraints required Stryker to move to a new EEPROM in 2022. This change interrupted communication capabilities between all SERFAS Probes manufactured on and after April 12th, 2022, and our SERFAS Energy Generator Console. The SERFAS Energy Generator Console is obsolete (circa 2012), non-serviceable and has a recommended service life of 2 years. |
YAP SOOK FONG ASSOCIATE HR MANAGER STRYKER CORPORATION (MALAYSIA) SDN. BHD. |
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15 Aug 2023 |
VITROS IMMUNODIAGNOSTIC PRODUCTS FERTILITY & PREGNANCY HORMONES & PROTEINS |
MDA/FCA/P0471-80842451-2023 |
IVDB7258323-129195 |
Ortho Clinical Diagnostics (QuidelOrtho™) received 12 complaints related to this issue as of 31-Jul-2023, we have received no complaints of biased results related to this issue nor have we experienced biased results during our investigation. |
MENG TSE LEEAU MANAGING DIRECTOR T T MEDICAL MANAGEMENT SDN BHD |
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21 Aug 2023 |
ORTHO-CLINICAL DIAGNOSTICS, INC. IMMUNOCHEMISTRY ENZYMES |
MDA/FCA/P0479-73186795-2023 |
IVDB96250352418 |
This notification is to inform you that Ortho Clinical Diagnostics (QuidelOrtho) has confirmed an issue involving VITROS Chemistry Products ALKP Slides and VITROS XT Chemistry Products TBIL-ALKP Slides. Samples with highly elevated ALKP activity may return a false-low result and not generate the Substrate Depletion Limit code (DP code). |
MENG TSE LEEAU MANAGING DIRECTOR T T MEDICAL MANAGEMENT SDN BHD |
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29 Aug 2023 |
URGENT PRODUCT CORRECTION NOTIFICATION Revised Storage Instructions for VITROS® Immunodiagnostic Products HBeAg Calibrators
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VITROS IMMUNODIAGNOSTIC PRODUCTS HBEAG |
MDA/FCA/P0487-91478488-2023 |
IVDD1508694518 |
QuidelOrtho (formerly Ortho Clinical Diagnostics) has become aware that due to a change in a raw material, VITROS® Immunodiagnostic Products HBeAg Calibrator, Lots 4880 and above, do not meet the current opened - reconstituted stability specification. |
MENG TSE LEEAU MANAGING DIRECTOR T T MEDICAL MANAGEMENT SDN BHD |
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22 Aug 2023 |
23TMMYFSCA01_Accuray Radixact Calisto Gantry Cover Bracket Inspection and Replacement_23TMFSCA04 |
RADIXACT TREATMENT DELIVERY SYSTEM |
MDA/FCA/P0481-10081602-2023 |
GC610521011418 |
It has been discovered that when utilizing the Jib Crane Assembly while servicing Radixact systems with a Calisto style gantry, that in some instances there is not enough clearance for the Jib Crane to function as intended. |
NG KEE YEAN TRANSMEDIC HEALTHCARE SDN BHD |