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FIELD CORRECTIVE ACTION LISTING FOR NOVEMBER 2024
The list below contains Medical Device’s Field Corrective Action for the month of November 2024. 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.
|
No |
Date received |
Title of FCA |
Affected Medical Device |
MDA Reference Number |
MDA Registration Number |
Local Establishment Contact Detail |
|
1 |
04/11/2024 |
SURGICAL NON ABSORBABLE SUTURE DSUCI MESALON |
MDA/FCA/P1041-83977166-2024 |
GC530501154418 |
MUZAMAL INDUSTRIES SDN BHD |
|
|
2 |
04/11/2024 |
SURGICAL NON ABSORBABLE SUTURES MEASSILK |
MDA/FCA/P1047-70219996-2024 |
GC872081264419 |
MUZAMAL INDUSTRIES SDN BHD |
|
|
3 |
04/11/2024 |
SURGICAL NON ABSORBABLE SUTURE DSUCI NAYLENE |
MDA/FCA/P1048-47394355-2024 |
GC655451103018 |
MUZAMAL INDUSTRIES SDN BHD |
|
|
4 |
05/11/2024 |
Atellica IM Total Thyroxine (T4) Reduced Pack Calibration Interval |
ATELLICA® IM TOTAL THYROXINE (T4) |
MDA/FCA/P1050-29591562-2024 |
IVDB79506172418 |
SIEMENS HEALTHCARE SDN. BHD. |
|
5 |
05/11/2024 |
I MMULITE and IMMULITE 1000 TNFα Positive Shift in the Lower End of the Analytical Measuring Range |
IMMULITE / IMMULITE 1000 TNF ALPHA |
MDA/FCA/P1051-94138530-2024 |
IVDB95844112218 |
SIEMENS HEALTHCARE SDN. BHD. |
|
6 |
05/11/2024 |
REAGENT RED BLOOD CELLS FOR ANTIBODY IDENTIFICATION |
MDA/FCA/P1052-55023039-2024 |
IVDD6204124-184229 |
BMS DIAGNOSTICS (M) SDN BHD |
|
|
7 |
05/11/2024 |
Access Intact PTH assay may produce falsely decreased results if EDTA and lithium heparin |
ACCESS BONE METABOLISM ASSAYS |
MDA/FCA/P1053-16976865-2024 |
IVDB8250522-107309 |
BECKMAN COULTER MALAYSIA SDN. BHD. |
|
8 |
06/11/2024 |
An unexpected decrease in calibrator reactivity of Liaison Mumps |
LIAISON® MUMPS |
MDA/FCA/P1055-81766066-2024 |
IVDC6664421-64864 |
DIAGNOSTICARE SDN BHD |
|
9 |
06/11/2024 |
WELCH ALLYN Q-STRESS CARDIAC STRESS TESTING SYSTEM |
MDA/FCA/P1056-82796840-2024 |
GB7445020-43257 |
WELCH ALLYN MALAYSIA SDN BHD |
|
|
10 |
06/11/2024 |
WELCH ALLYN DIAGNOSTIC CARDIOLOGY SUITE RESTING ECG |
MDA/FCA/P1057-85270993-2024 |
GB2624622-95832 |
WELCH ALLYN MALAYSIA SDN BHD |
|
|
11 |
07/11/2024 |
WELCH ALLYN H-SCRIBE HOLTER ANALYSIS SYSTEM |
MDA/FCA/P1058-20052771-2024 |
GB9417320-44399 |
WELCH ALLYN MALAYSIA SDN BHD |
|
|
12 |
08/11/2023 |
External Drainage and Monitoring Systems Potential for Stopcock Cracking and Leaking |
EDM VENTRICULAR CATHETER |
MDA/FCA/P1059-53506435-2024 |
GD81123630118 |
MEDTRONIC MALAYSIA SDN BHD |
|
13 |
08/11/2024 |
BECKER EXTERNAL DRAINAGE AND MONITORING SYSTEM WITH ACCESSORIES |
MDA/FCA/P1061-92499006-2024 |
GMD15801665618A |
MEDTRONIC MALAYSIA SDN BHD |
|
|
14 |
12/11/2024 |
TRACHEAL TUBE INTRODUCERS |
MDA/FCA/P1064-49855518-2024 |
GA3612123-135427 |
PRIMED MEDICAL SDN BHD |
|
|
15 |
13/11/2024 |
LIAISON® CALPROTECTIN |
MDA/FCA/P1066-72252284-2024 |
IVDB2748121-59596 |
DIAGNOSTICARE SDN BHD |
|
|
16 |
15/11/2024 |
ACCESS UNCONJUGATED ESTRIOL |
MDA/FCA/P1070-50251327-2024 |
IVDB2555024-162080 |
BECKMAN COULTER MALAYSIA SDN. BHD. |
|
|
17 |
16/11/2024 |
INTENSIVE CARE VENTILATOR |
MDA/FCA/P1069-67699223-2024 |
GC1472322-99279 |
4U-TECH CORPORATION SDN BHD |
|
|
18 |
18/11/2024 |
EZ GLIDE AORTIC CANNULA |
MDA/FCA/P1073-75601890-2024 |
GD4312822-85969 |
EDWARDS LIFESCIENCES (MALAYSIA) SDN BHD |
|
|
19 |
18/11/2024 |
Carryover of cTnI may generate a falsely elevated Access hsTnI |
ACCESS HSTNI |
MDA/FCA/P1075-66021263-2024 |
IVDC6465523-134189 |
BECKMAN COULTER MALAYSIA SDN. BHD. |
|
20 |
19/11/2024 |
MINICAP EXTENDED LIFE PD TRANSFER SET WITH TWIST CLAMP - EXTRA SHORT |
MDA/FCA/P1076-20116459-2024 |
GB18829788518 |
BAXTER HEALTHCARE (MALAYSIA) SDN. BHD. |
|
|
21 |
21/11/2024 |
Atellica IM Total Triiodothyronine (T3) Pack Calibration Interval Reduction |
ATELLICA® IM TOTAL TRIIODOTHYRONINE (T3) |
MDA/FCA/P1080-76579166-2024 |
IVDB66176172318 |
SIEMENS HEALTHCARE SDN. BHD. |
|
22 |
25/11/2024 |
Unintentional radiation release due to defective hand switches on mobile X-ray devices |
ZIEHM VISION FD |
MDA/FCA/P1082-27229305-2024 |
GC7506722-98689 |
BEST CONTACT (M) SDN BHD |
|
23 |
26/11/2024 |
ZIEHM VISION RFD 3D |
MDA/FCA/P1083-63825633-2024 |
GC6294722-87217 |
BEST CONTACT (M) SDN BHD |
|
|
24 |
26/11/2024 |
ZIEHM VISION RFD |
MDA/FCA/P1084-96734233-2024 |
GC5679323-128206 |
||
|
25 |
28/11/2024 |
Epoc NXS Host SW | NXS Host Potential Patient Demographic Error Due to Connectivity Issue |
EPOC BLOOD ANALYSIS SYSTEM |
MDA/FCA/P1087-82140756-2024 |
IVDC7557621-75750 |
SIEMENS HEALTHCARE SDN. BHD. |
|
26 |
29/11/2024 |
SLE INFANT/NEONATE VENTILATORS |
MDA/FCA/P1085-75509886-2024 |
GC2846224-170607 |
DAYA CERGAS (M) SDN BHD |
|
|
27 |
29/11/2024 |
MEERA, MEERA ST |
MDA/FCA/P1065-99787692-2024 |
GA2599721-82114 |
RBD HEALTHCARE SDN BHD |
