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MEDICAL DEVICE FIELD CORRECTIVE ACTION LISTING FEBRUARY 2026
The list below contains Medical Device’s Field Corrective Action for the month of February 2026. 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.
MEDICAL DEVICE FIELD CORRECTIVE ACTION LISTING FEBRUARY 2026
|
No. |
Date Received |
Title of FCA |
Affected Medical Device |
MDA Reference Number |
MDA Registration Number |
Local Establishment Contact Detail |
|
1 |
02/02/2026 |
Xpert® Carba-R Sample Reagent Vial with Incorrect Volume |
XPERT CARBA-R ASSAY |
IVDC6457221-74902 |
RADIOMETER MALAYSIA SDN. BHD. |
|
|
2 |
03/02/2026 |
(PHC26-01.A.OUS) Protein S Ac kit lot 03628 – Protein S Ac Reagent lot 562954 may be cloudy after reconstitution. |
SIEMENS PROTEIN S AC |
IVDC4691624-166628 |
SYSMEX (MALAYSIA) SDN. BHD. |
|
|
3 |
04/02/2026 |
Discontinuation use and repair of TU2000 TRYTABLE |
MMT TRYTABLE TU2000 |
GA2807724-178157 |
MEDI-LIFE (M) SDN. BHD. |
|
|
4 |
05/02/2026 |
FCA2525: TS-10: Lift Drop Incident during Rack Jam Clearence |
XR-SERIES AUTOMATED HEMATOLOGY ANALYZER |
IVDB6506724-170755 |
SYSMEX (MALAYSIA) SDN. BHD. |
|
|
5 |
05/02/2026 |
Olympus Emphasis on Strict Adherence to Instructions for Use (IFU) |
EUS ULTRASONIC VIDEOSCOPE SYSTEM |
GB79514818718 |
OLYMPUS (MALAYSIA) SDN. BHD. |
|
|
6 |
05/02/2026 |
FA-001491- Beckman Coulter has determined that some DxC 700 AU and AU5800 Clinical Chemistry Analyzers may unexpectedly generate some errors due to Microsoft® SQL Server® 2022 Express issue. If this issue occurs the system may stop analyzing, and cause delays in reporting patient test results to physicians. |
DxC 700 Analyzer |
IVDA5467424-161450 |
BECKMAN COULTER MALAYSIA SDN. BHD. |
|
|
7 |
05/02/2026 |
LIFECODES LSA Class I Stability Failure |
LIFECODES SINGLE ANTIGEN KITS |
IVDC75845124518 |
BMS DIAGNOSTICS (M) SDN BHD |
|
|
8 |
06/02/2026 |
Field Safety Notice - STA Liatest D-Di Plus. Stago has identified a positive bias in D-Dimer results across the analytical range for the affected lots. |
STA® - LIATEST® D-DI PLUS |
MDA/FCA/P1651-19481110-2026 |
IVDC5347522-90795 |
ALL EIGHTS (M) SDN BHD |
|
9 |
06/02/2026 |
015 FSCA IMC 26-03 IMMULITE 2000 EPO and IMMULITE EPO Control Module | EPO Adjustor and Control Module Open Vial Instability |
IMMULITE 2000 EPO |
MDA/FCA/P1653-60601548-2026 |
IVDB1287363017 |
SIEMENS HEALTHCARE SDN. BHD. |
|
10 |
09/02/2026 |
CVG-21-Q3-21 Rev AC, HVAD Pump Failure to Restart Algorithm C |
HEARTWARE™ VENTRICULAR ASSIST DEVICE (HVAD™) ACCESSORIES SYSTEM |
MDA/FCA/P1654-58219598-2026 |
GD2555223-122718 |
MEDTRONIC MALAYSIA SDN BHD cherie.ang@medtronic.com |
|
11 |
10/02/2026 |
Olympus to Provide Impacted Customer With a Copy of the Instructions for Use (IFU) |
CELONLAB ENT SYSTEM |
MDA/FCA/P1659-81299459-2026 |
GC35106930618 |
OLYMPUS (MALAYSIA) SDN. BHD. |
|
12 |
11/02/2026 |
Important Security Notice for Centricity Universal Viewer Centricity Universal Viewer (GB5328025-213680) |
CENTRICITY UNIVERSAL VIEWER |
MDA/FCA/P1663-28353720-2026 |
GB5328025-213680 |
GE HEALTHCARE SDN. BHD |
|
13 |
12/02/2026 |
GEM PREMIER 5000 BLOOD GAS SYSTEM Issue: Performance issue with specific GEM PAKs for the GEM Premier 5000 with iQM2 (Intelligent Quality Management) may experience an increased incidence of “Process Control Solution Not Detected” (PCSND) errors during warm-up, including consecutive occurrences, resulting in GEM PAK ejection and requiring a new GEM PAK insertion. |
GEM PREMIER 5000 BLOOD GAS SYSTEM |
MDA/FCA/P1664-90928076-2026 |
IVDC33500201118 |
STRAITS SCIENTIFIC (M) SDN BHD |
|
14 |
13/02/2026 |
Device Name: HEMOSIL REAGENTS - HemosIL Factor V Leiden Issue: Reduction in the on-board instrument stability claim for all current and future lots of HemosIL Factor V Leiden when used on the ACL TOP Family, ACL TOP Family 50 Series, and ACL TOP Family 70 Series hemostasis systems. |
HEMOSIL REAGENTS |
IVDB75996368519 |
STRAITS SCIENTIFIC (M) SDN BHD |
|
|
15 |
14/02/2026 |
FA1514 MiniMed Pump Placement with Respect to Infusion Site |
MINIMED 700 INSULIN PUMP AND KIT |
GC8922821-64034 |
MEDTRONIC MALAYSIA SDN BHD |
|
|
16 |
14/02/2026 |
FA1514 MiniMed Pump Placement with Respect to Infusion Site |
MINIMED 780G SYSTEM AND ACCESSORIES |
GC4190021-62126 |
MEDTRONIC MALAYSIA SDN BHD |
|
|
17 |
14/02/2026 |
FA1514 MiniMed Pump Placement with Respect to Infusion Site |
PARADIGM VEO INSULIN PUMP |
GC8904122-88631 |
MEDTRONIC MALAYSIA SDN BHD |
|
|
18 |
14/02/2026 |
FA1514 MiniMed Pump Placement with Respect to Infusion Site |
MINIMED 640G SYSTEM AND ACCESSORIES |
GC8430922-106837 |
MEDTRONIC MALAYSIA SDN BHD |
|
|
19 |
14/02/2026 |
FA1514 MiniMed Pump Placement with Respect to Infusion Site |
THE MINIMED PARADIGM INSULIN PUMP |
GC8737122-88537 |
MEDTRONIC MALAYSIA SDN BHD |
|
|
20 |
19/02/2026 |
2026-CC-SRC-002: Trilogy Evo, Trilogy Evo O2, Trilogy EV300 Non-pneumatic Nebulizer Use, Flow Sensor Nebulized Aerosol Deposition, and Obstruction Alarm |
TRILOGY EVO |
GC2627520-39891 |
PHILIPS MALAYSIA SENDIRIAN BERHAD |
|
|
21 |
19/02/2026 |
2026-CC-SRC-002: Trilogy Evo, Trilogy Evo O2, Trilogy EV300 Non-pneumatic Nebulizer Use, Flow Sensor Nebulized Aerosol Deposition, and Obstruction Alarm |
TRILOGY EV300 |
GC5498920-50666 |
PHILIPS MALAYSIA SENDIRIAN BERHAD |
|
|
22 |
20/02/2026 |
Field Safety Notification for Locking adapter/s to the Leksell Gamma Knife |
LEKSELL GAMMA KNIFE (LGK) |
GC9257822-110526 |
NYPRAX BUSINESS SOLUTIONS |
|
|
25 |
23/02/2026 |
Confirming Intended Reagent is Loaded During Manual Load Procedures |
VITROS IMMUNODIAGNOSTIC PRODUCTS FERTILITY & PREGNANCY HORMONES & PROTEINS |
IVDB7258323-129195 |
T T MEDICAL MANAGEMENT SDN BHD |
|
|
26 |
23/02/2026 |
VITROS™ Immunodiagnostic Products Progesterone 2 Calibrators – Potential for Calibration or Quality Control Failures |
VITROS IMMUNODIAGNOSTIC PRODUCTS PROGESTERONE 2 |
IVDB3167525-214895 |
T T MEDICAL MANAGEMENT SDN BHD |
|
|
29 |
25/02/2026 |
ABL90 FLEX PLUS - Analyzer may abort capillary samples |
ABL90 FLEX |
MDA/FCA/P1687-55374265-2026 |
IVDC5590952317 |
RADIOMETER MALAYSIA SDN. BHD |
|
30 |
26/02/2026 |
Device Name: HemosIL Factor XIII Antigen Issue: Reduction in the on-board instrument stability claim for all in-date and future lots of HemosIL Factor XIII Antigen (Part No. 0020201300) when used on the ACL TOP Family, ACL TOP Family 50 Series, and ACL TOP Family 70 Series hemostasis systems. |
HEMOSIL FACTOR XIII ANTIGEN |
IVDC2356823-153931 |
STRAITS SCIENTIFIC (M) SDN BHD |
|
|
31 |
27/02/2026 |
|
ATELLICA® CH ENZYMATIC HEMOGLOBIN A1C (A1C_E) |
MDA/FCA/P1689-24384977-2026 |
IVDB9845619-35149 |
SIEMENS HEALTHCARE SDN. BHD. |
* The information contained in the Medical Device Authority Field Corrective Action database is released under Regulation 7 (8) and Regulation 8 (5) of Malaysia’s Medical Device Regulations 2019.
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