MEDICAL DEVICE FIELD CORRECTIVE ACTION LISTING SEPTEMBER 2025
The list below contains Medical Device’s Field Corrective Action for the month of September 2025. 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 SEPTEMBER 2025
|
No. |
Date Received |
Title of FCA |
Affected Medical Device |
MDA Reference Number |
MDA Registration Number |
Local Establishment Contact Detail |
|
1. |
03/09/2025 |
ROTEM® sigma ROTROL P Issue: Werfen has identified that the ROTEM sigma ROTROL P lot 32400122, has a higher than expected likelihood of generating quality control out of range results n INTEM C CT or HEPTEM C CT assays in conjunction with cartridge lots numbers between S240101 and S250209. |
ROTE M® SIGMA |
IVDC10235825-198676 |
STRAITS SCIENTIFIC (M) SDN BHD |
|
|
2. |
11/09/2025 |
Unexpected shutdown of the Cardiosave IABP |
CARDIOSAVE INTRA-AORTIC BALLOON PUMP |
GC2992923-137663 |
RBD HEALTHCARE SDN BHD |
|
|
3. |
09/09/2025 |
Olympus to Provide Updates to the Instruction for Use (IFU) for Olympus Bronchofiberscope, Bronchovideoscope. |
EVIS EXERA III BRONCHOVIDEOSCOPE SYSTEM |
GB58878308917 |
OLYMPUS (MALAYSIA) SDN. BHD |
|
|
4. |
05/09/2025 |
Field Safety Notice (FSN) relating to the stability of the Oxazepam analyte contained in Multi-Drug Calibrator / Control products |
URINE ENZYME IMMUNOASSAY |
IVDB10629319-34166 |
ABBOTT DIAGNOSTICS HEALTH SDN BHD |
|
|
5. |
10/09/2025 |
DEFIGARD HD-7 - intermittent contact with removable adult defibrillation paddles (IM00967) |
DEFIGARD HD-7 |
GC10563625-202352 |
SCHILLER ASIA PACIFIC SDN. BHD. [email protected] |
|
|
6. |
10/09/2025 |
MAC™ VU360 RESTING ECG ANALYSIS SYSTEM MAC VU360 Acquisition Module Holder |
MAC™ VU360 RESTING ECG ANALYSIS SYSTEM |
GB4693721-52965 |
GE HEALTHCARE SDN. BHD |
|
|
7. |
10/09/2025 |
Failure modes of Heartstring Seal |
HEARTSTRING III PROXIMAL SEAL SYSTEM |
GB7745523-127193 |
RBD HEALTHCARE SDN BHD |
|
|
8. |
19/09/2025 |
Field action for InteliQ Immunology Control to revise the in-use stability claim for anti-cyclic Citrullinated Peptide (anti-CCP). |
INTELIQ IMMUNOLOGY CONTROL |
IVDB9987521-63532 |
CHEMOPHARM SDN BHD |
|
|
9. |
18/09/2025 |
PLT-I value, low recovery and high variability |
SYSMEX_HAEMATOLOGY_OTHER HAEMATOLOGY TESTS |
IVDB17531114618 |
SYSMEX (MALAYSIA) SDN. BHD. |
|
|
10. |
18/09/2025 |
Lower calcium recovery in Level 3 of Liquid Unassayed Multiqual. |
LIQUID UNASSAYED MULTIQUAL CONTROL |
IVDB6550720-49432 |
CHEMOPHARM SDN BHD |
|
|
11. |
18/09/2025 |
Lower calcium recovery in Level 3 of InteliQ Assayed Multiqual Control |
INTELIQ ASSAYED MULTIQUAL CONTROL |
IVDC6673524-164751 |
CHEMOPHARM SDN BHD |
|
|
12. |
18/09/2025 |
Lower calcium recovery in InteliQ Assayed Multiqual Control |
INTELIQ ASSAYED MULTIQUAL CONTROL |
IVDC6673524-164751 |
CHEMOPHARM SDN BHD |
|
|
13. |
19/09/2025 |
FA18SEP2025 Alinity hq Analyzer software versions 5.0 to 5.10.1 does not visibly apply appropriate flag IG and NEU results when saturation is present, which may prevent users from recognizing potentially impacted values. |
ALINITY HQ ANALYZER |
MDA/FCA/P1415-68416906-2025 |
IVDB31515121518 |
ABBOTT LABORATORIES (MALAYSIA) SDN. BHD. |
|
14. |
19/09/2025 |
Lower calcium recovery in InteIiQ Assayed Multiqual Control. |
LIQUICHEK ASSAYED CHEMISTRY CONTROL |
IVDB2758923-133131 |
CHEMOPHARM SDN BHD |
|
|
15. |
22/09/2025 |
Lyphochek Assayed Chemistry Control – The reconstituted and refrigerated storage stability claim for Bilirubin (Direct) has been reduced to 4 days. |
LYPHOCHEK® ASSAYED CHEMISTRY CONTROL |
IVDC97925103018 |
CHEMOPHARM SDN BHD |
|
|
16. |
25/09/2025 |
Increased trend of complaint of probes unexpectedly failing to actuate and cut during use |
CONSTELLATION VISION SYSTEM |
GC96073327017 |
ALCON LABORATORIES (M) SDN. BHD. |
|
|
17. |
26/09/2025 |
AW SERVER 3.2 Unauthorized access to the Service Tools Web Interface |
AW SERVER 3.2 |
GB3800423-134964 |
GE HEALTHCARE SDN. BHD |
|
|
18. |
30/09/2025 |
URGENT: MEDICAL DEVICE CUSTOMER NOTICE CADDTM Medication Cassette Reservoirs |
CADD SOLIS AMBULATORY INFUSION PUMP |
GC5586521-80774 |
PRIMED MEDICAL SDN BHD |
|
|
19. |
30/09/2025 |
Device name: HemosIL Quality Controls Discontinuation of Reconstituted Stability Claims at 2-8⁰C. |
HEMOSIL CONTROL ASSAYED |
IVDC87652271518 |
STRAITS SCIENTIFIC (M) 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.
