FIELD CORRECTIVE ACTION LISTING FOR JANUARY AND FEBRUARY 2023
The list below contains Medical Device’s Field Corrective Action for the month of January and February 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 –
- The return of the medical device to the establishment;
- Modification of the medical device;
- Exchange of the medical device;
- Destruction of medical device; or
- 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 |
|
26 Jan 2023 |
ALINITY M HBV |
MDA/FCA/P0208-47976109-2023 |
IVDC9888620-39112 |
Two studies were conducted to stress the overall system using study designs factoring the worst case conditions of carryover using high titer samples (100,000,000 IU/mL). Both studies processed samples through Sample Input/Processing and the AMP tray. This additional information is being communicated to provide updated details on the total carryover rate and the calculated method used to determine the carryover rate. |
VIOLA SUBHASHINI PETERS REGULATORY AFFAIRS & QUALITY ASSURANCE MANAGER ABBOTT MEDICAL (MALAYSIA) SDN. BHD. |
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7 Feb 2023 |
ACCESS HYBRITECH PSA |
MDA/FCA/P0226-56734340-2023 |
IVDC94989146418 |
FA-23001 Access 2 Immunoassay Analyzer (81600N); Access 2 Immunoassay Analyzer, Refurbished (386220); Access 2 Immunoassay Analyzer-Refurbished (A65531); and Access 2 Section, DxC 600i Packaged (A25640). |
NUR AISHAH BINTI ABD AZIZ RA SPECIALIST BECKMAN COULTER MALAYSIA SDN. BHD. |
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3 Feb 2023 |
AQUIOS TETRA-1 PANEL AND AQUIOS TETRA-2 PANEL MONOCLONAL ANTIBODY |
MDA/FCA/P0230-30235363-2023 |
IVDC1382943917 |
AQUIOS IMMUNO-TROL Cells (PN: B23535 -, Lots: 6170210K and 6170215K) has the incorrect product name on the packaging box label. The label states AQUIOS IMMUNO-TROL Low Cells instead of AQUIOS IMMUNO-TROL Cells. |
NUR AISHAH BINTI ABD AZIZ RA SPECIALIST BECKMAN COULTER MALAYSIA SDN. BHD. |
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8 Feb 2023 |
INSTRUMENT AND ACCESSORIES |
MDA/FCA/P0235-57416041-2023 |
IVDA19892104418 |
Bio-Rad has observed an issue regarding blood grouping analyzer IH-1000 software version 04.08.11 intended to be used with the Data Management Software IH-Com version 5.2.5 Service Pack. |
APPHIA EU CHIA HUI SENIOR REGULATORY & QA BIOMARKETING SERVICES (M) SDN BHD |
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7 Feb 2023 |
DAKO_HISTOLOGY/ CYTOLOGY HISTOLOGY/CYTOLOGY REAGENTS_CLUSTER 2 |
MDA/FCA/P0216-24859276-2023 |
IVDB83493297718 |
Based on investigations, there is a possibility that the user could use the wrong wash buffer resulting in signals being too weak. However, the probability of harm is deemed to be improbable. |
HOW KIAN MING MANAGING DIRECTOR BITA LIFESCIENCE SDN. BHD. |
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7 Feb 2023 |
Anesthesia Set Flex, Latex Free (MP00303) - Contaminated Flex Ventilation hoses |
FABIUS FAMILY |
MDA/FCA/P0222-28167425-2023 |
GC52775717518 |
In the course of internal quality controls, we have noticed that some of our Flex ventilation hoses have contaminations. Due to a deviation in the manufacturing process, components of the hose material remained as particles inside the hoses. |
BEATRICE MAH WAN XIN QUALITY AND REGULATORY AFFAIR SPECIALIST DRAEGER MALAYSIA SDN BHD |
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25 Jan 2023 |
Field Correction Notice (FCN) MCC-22-009-NU, Power Backup Batteries Flow Family |
MAQUET FLOW-I ANESTHESIA SYSTEM |
MDA/FCA/P0203-16337580-2023 |
GC25644700318 |
There is an issue with the Power Backup Batteries at Flow Anesthesia System, i.e. Flow-c, Flow-e and Flow-i (serial number >20000). |
HUDA TAJUDDIN REGULATORY SPECIALIST IDS MEDICAL SYSTEMS (M) SDN BHD |
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10 Jan 2023 |
Field Safety Notice for ANSPACH™ EMAX™ 2 Plus/EG1™ Electric Systems-Craniotome Attachments |
ANSPACH EMAX2 PLUS HIGH-SPEED ELECTRIC SYSTEM |
MDA/FCA/P0187-40122518-2023 |
GB78971760518 |
It was identified through 2 complaints (China) that under unknown circumstances, the ball bearings in the CRANI-A (Adult Craniotome ANSPACH Power Tools Attachment) came out of the attachment intra-operatively. The devices were not returned for investigation, however, the information available shows that the devices far exceeded the recommended service interval. |
WONG MEE KIM SENIOR MANAGER, REGULATORY AFFAIRS JOHNSON & JOHNSON SDN BHD |
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7 Feb 2023 |
ACTIVA NEUROSTIMULATOR FOR DEEP BRAIN STIMULATION SYSTEM |
MDA/FCA/P0228-29375631-2023 |
GD9997822-89709 |
Medtronic has identified through a complaint assessment, that the Medtronic WR9200 recharger, contained within the Recharger Kit RS6200, have had occurrences where the WR device becomes unresponsive. This issue may occur when the WR is fully depleted and the WR is placed on the dock and quickly removed within 20 seconds, interrupting the initialization routine. |
CHOW SOON YEE REGULATORY AFFAIRS LEAD MEDTRONIC MALAYSIA SDN BHD |
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27 Jan 2023 |
2022-CC-HRC-013 - Philips Respironics V680 Ventilator Market Removal |
V680 VENTILATOR |
MDA/FCA/P0214-63340223-2023 |
GC47771332217 |
The V680 Ventilator has been identified as potentially having the following issue: During dual-limb invasive ventilation, a patient cough of sufficient magnitude to drive circuit pressures above 95 cmH2O for longer than 150 milliseconds may cause a “Vent Inoperative 1008: Machine and Proximal Pressure Sensors Failed” alarm, which will cause the V680 ventilator to cease therapy and the ventilator will not function, however, it will remain powered on. |
ZAM ZARINA BINTI MAT ALI Q&R MANAGER PHILIPS MALAYSIA SDN BERHAD |
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2 Feb 2023 |
FCO86600065-V60/V60 Plus Ventilator - Information Regarding High Flow Therapy Option |
V60 VENTILATOR |
MDA/FCA/P0220-38304539-2023 |
GC26388685318 |
In situations where the high flow therapy pressure reaches the maximum limit, the ventilator will sound a low priority, “Cannot Reach Target Flow (CRTF)” alarm and reduces the pressure – which also simultaneously decreases the flow rate to a level below what was set by the clinician for as long as the condition persists. |
ZAM ZARINA BINTI MAT ALI Q&R MANAGER PHILIPS MALAYSIA SDN BERHAD |
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2 Feb 2023 |
FCO86600065-V60/V60 Plus Ventilator - Information Regarding High Flow Therapy Option |
V60 PLUS VENTILATOR |
MDA/FCA/P0224-90046732-2023 |
GC5712719-34776 |
The V60/V60 Plus ventilators equipped with High Flow Therapy option (Software Version 3.00 and Software Version 3.10) are designed with a safety mechanism to limit the amount of pressure that can be delivered to the patient when the ventilator is operating in High Flow Therapy. |
ZAM ZARINA BINTI MAT ALI Q&R MANAGER PHILIPS MALAYSIA SDN BERHAD |
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30 Jan 2023 |
ELECSYS TROPONIN T HS |
MDA/FCA/P0200-77537535-2023 |
IVDC3527520-49005 |
In some cases, affected samples showed observable turbidity and a pellet fraction was visible after centrifugation of affected samples. In this regard, it is important to remind to the users the sample handling guidance given in the Elecsys Troponin T hs / STAT assay method sheet. |
KOH WAI CHIN SENIOR REGULATORY AFFAIRS SPECIALIST ROCHE DIAGNOSTICS (M) SDN. BHD. |
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10 Jan 2023 |
HCG |
MDA/FCA/P0191-93923510-2023 |
IVDB57119112118 |
Preliminary testing carried out by Siemens Technical Operations using HCG kit Lots 469 and 471 were assessed using 89 Normal Female Samples (3 replicates), and 18 Urine Samples (3 replicates). On HCG Kit Lot 469 additional samples were assessed using 20 1st, 2nd and 3rd Trimester Samples (3 replicates), and 4 normal female samples (100 replicates). In this testing only the first replicate of one sample (low sample) on kit lot 471 was identified as falsely elevated. |
LAM YEN LI HEAD OF QUALITY & TECHNOLOGY SIEMENS HEALTHCARE SDN BHD |
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13 Jan 2023 |
AIMC 23-03 Atellica IM Folate – Improper Calibration for Serum Samples. |
ATELLICA IM FOLATE (FOL) |
MDA/FCA/P0195-99198869-2023 |
IVDB12482267618 |
Siemens’s investigation found the complainants had received the Atellica IM Folate kit lots ending in 337 and higher or ADVIA Centaur Folate kit lots ending in 336 and higher and were using a whole blood calibration. The communications will provide instructions to follow in order to successfully implement the enhancement to the Atellica IM Folate and ADVIA Centaur Folate assays and obtain correct results for serum samples |
LAM YEN LI HEAD OF QUALITY & TECHNOLOGY SIEMENS HEALTHCARE SDN BHD |
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13 Jan 2023 |
AIMC 23-03 ADVIA Centaur XP and XPT Folate – Improper Calibration for Serum Samples. |
ADVIA CENTAUR® FOLATE (FOL) |
MDA/FCA/P0196-98130653-2023 |
IVDB53423163118 |
Siemens’s investigation found the complainants had received the Atellica IM Folate kit lots ending in 337 and higher or ADVIA Centaur Folate kit lots ending in 336 and higher and were using a whole blood calibration. The communications will provide instructions to follow in order to successfully implement the enhancement to the Atellica IM Folate and ADVIA Centaur Folate assays and obtain correct results for serum samples |
LAM YEN LI HEAD OF QUALITY & TECHNOLOGY SIEMENS HEALTHCARE SDN BHD |
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26 Jan 2023 |
Dimension® Hemoglobin A1c Kit |
MDA/FCA/P0212-12201257-2023 |
IVDB10358919-32043 |
The Dimension A1C and AHDL assays use lot specific scalers. Siemens Healthineers has identified the scaler units of measure listed in the header at the top of the scaler label on the carton of the A1C and AHDL lots listed in the Customer Notification are incorrect. |
LAM YEN LI HEAD OF QUALITY & TECHNOLOGY SIEMENS HEALTHCARE SDN BHD |
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27 Jan 2023 |
DIMENSION AUTOMATED HDL CHOLESTEROL (AHDL) |
MDA/FCA/P0218-54267676-2023 |
IVDB94468136418 |
The Dimension A1C and AHDL assays use lot specific scalers. Siemens Healthineers has identified the scaler units of measure listed in the header at the top of the scaler label on the carton of the A1C and AHDL lots listed in the Customer Notification are incorrect. |
LAM YEN LI HEAD OF QUALITY & TECHNOLOGY SIEMENS HEALTHCARE SDN BHD |
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7 Feb 2023 |
ATELLICA CH 930 ANALYZER |
MDA/FCA/P0232-37520218-2023 |
IVD34641418218A |
Multiple customer complaints have been received for falsely elevated Magnesium (Mg) results on the Atellica CH 930 when Atellica CH LDL Cholesterol Direct (DLDL), Atellica CH Total Protein II (TP) or Atellica CH Triglycerides (Trig) is the prior test processed. Addition investigation also indicated carryover from Trig_2 into Mg resulting in elevated results. |
LAM YEN LI HEAD OF QUALITY & TECHNOLOGY SIEMENS HEALTHCARE SDN BHD |
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12 Jan 2023 |
SYSMEX HAEMATOLOGY OTHER HAEMATOLOGY TESTS |
MDA/FCA/P0193-18323983-2023 |
IVDB17531114618 |
There were 2 cases from XP-300 analyzer reported regarding burning odor (1 case) and flames (1 case), the users disconnected analyzer from power immediately and no serious injury or damage was reported. Sysmex investigated that the problem happened due to complication of the dust piling up on the backside of PCB No. 4087T1 which is used on both XP-100 and XP-300. |
JANICE HO SU YI SENIOR REGULATORY AFFAIRS SPECIALIST SYSMEX (MALAYSIA) SDN. BHD. |
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26 Jan 2023 |
SYSMEX AUTOMATED BLOOD COAGULATION ANALYZER_CA-600 SERIES |
MDA/FCA/P0205-39101804-2023 |
IVDC8240021-69698 |
The IC Chip in CARD_ASSY NO. 18 (MEMORY) has been changed due to obsoletion of the previous IC Chip. The changed IC Chip is more vulnerable to external electrical noise than the previous IC Chip. |
JANICE HO SU YI SENIOR REGULATORY AFFAIRS SPECIALIST SYSMEX (MALAYSIA) SDN. BHD. |
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26 Jan 2023 |
FCA2215 CN Series unintended sample arm A errpr (error#32502) |
Sysmex Automated Coagulation Analyzer CN Series |
MDA/FCA/P0206-93403279-2023 |
IVDC6362721-66356 |
Sysmex has found the CN series Production failure trend increasing with this error. As the result of investigation, the cause is with insufficient belt tension at the sample arm |
JANICE HO SU YI SENIOR REGULATORY AFFAIRS SPECIALIST SYSMEX (MALAYSIA) SDN. BHD. |