FIELD CORRECTIVE ACTION LISTING FOR JULY 2024
The list below contains Medical Device’s Field Corrective Action for the month of July 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 |
01/07/2024 |
LUMINOS AGILE MAX |
MDA/FCA/P0875-84172537-2024 |
GC74703683318 |
SIEMENS HEALTHCARE SDN. BHD. FRAZER RODERICK JOHN |
|
|
2 |
02/07/2024 |
Program Update and Distribution of corrected barcode labels for platelet aggregation reagents |
Sysmex Automated Coagulation Analyzer CN Series |
MDA/FCA/P0871-67884140-2024 |
IVDC6362721-66356 |
SYSMEX (MALAYSIA) SDN. BHD. CHEAH KIT YIN |
|
3 |
04/07/2024 |
VENTANA ANTI-CD10 (SP67) RABBIT MONOCLONAL PRIMARY ANTIBODY |
MDA/FCA/P0880-10849542-2024 |
IVDC72765328118 |
ROCHE DIAGNOSTICS (M) SDN. BHD. HENG CHAI YIN |
|
|
4 |
08/07/2024 |
DEFIGARD TOUCH 7 |
MDA/FCA/P0883-51787926-2024 |
GC9551022-105940 |
SCHILLER ASIA PACIFIC SDN. BHD. LIM THIAM HONG |
|
|
5 |
11/07/2024 |
ZIMMER CPT HIP SYSTEM |
MDA/FCA/P0878-63055729-2024 |
GC85670779318 |
ZIMMER MEDICAL (MALAYSIA) SDN BHD SIEW LIP FUI |
|
|
6 |
11/07/2024 |
Possible alarm 113 malfunction, leading to inconsistent water temperature control in patient control mode |
ARCTIC SUN® TEMPERATURE MANAGEMENT SYSTEM |
MDA/FCA/P0881-16369583-2024 |
GC7671223-142632 |
BECTON DICKINSON SDN BHD LIM PUI SAN |
|
7 |
11/07/2024 |
Potential for Positive Bias When Using VITROS® Immunodiagnostic Products Free T3 Reagent Pack |
VITROS IMMUNODIAGNOSTIC PRODUCTS THYROID FUNCTION MARKERS |
MDA/FCA/P0886-15744602-2024 |
IVDB6427423-132903 |
TT MEDICAL MANAGEMENT SDN BHD MENG TSE LEEAU |
|
8 |
15/07/2024 |
CARELINK® PROGRAMMER AND ACCESSORIES |
MDA/FCA/P0888-18545330-2024 |
GC7679323-137683 |
MEDTRONIC MALAYSIA SDN BHD YAM KIN HUNG |
|
|
9 |
15/07/2024 |
CARELINK® PROGRAMMER AND ACCESSORIES |
MDA/FCA/P0889-24398723-2024 |
GC7679323-137683 |
MEDTRONIC MALAYSIA SDN BHD YAM KIN HUNG |
|
|
10 |
18/07/2024 |
HeartStart Intrepid Monitor/Defibrillator (867172) Intermittent ECG Waveforms |
HEARTSTART INTREPID |
MDA/FCA/P0891-72675966-2024 |
GC2897720-42451 |
PHILIPS MALAYSIA SDN BERHAD CHAN JIN HOE |
|
11 |
18/07/2023 |
McGRATH MAC Video Laryngoscope |
MDA/FCA/P0892-85787731-2024 |
GA7934120-46549 |
MEDTRONIC MALAYSIA SDN BHD YAM KIN HUNG |
|
|
12 |
24/07/2024 |
PROTEUS XR/F ET, PROTEUS XR/F ST |
MDA/FCA/P0896-73435367-2024 |
GC6842320-44034 |
GE HEALTHCARE SDN. BHD LIM SOCK SIANG |
|
|
13 |
24/07/2024 |
Intermittent IRISpec CB ketone and glucose control failure, resulting in false positive results when used in conjunction with iChemVELOCITY Urine Chemistry Strips. |
CHEM VELOCITY URINE CHEMISTRY SYSTEM |
MDA/FCA/P0897-25704328-2024 |
IVDB2172623-115162 |
BECKMAN COULTER MALAYSIA SDN. BHD. ONG NGUAN CHING |
|
14 |
25/07/2024 |
HeartMate 3 System Controller- may have a lifted screen at the edge (lifted user interphase) |
HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM |
MDA/FCA/P0900-99571426-2024 |
GD4151721-74880 |
ABBOTT MEDICAL (MALAYSIA) SDN. BHD. YUMITRA A/P DHORAI RAJA |
|
15 |
26/07/2024 |
Power Express Centrifuge has potential of Detached Metal Parts from Sample Holders |
Power Express Sample Processing System PLC |
MDA/FCA/P0901-51080179-2024 |
IVDA3310722-103227 |
BECKMAN COULTER MALAYSIA SDN. BHD. ONG NGUAN CHING |
|
16 |
26/07/2024 |
Increased complaints related to sharpness for specific ophthalmic knives |
ALCON CUTTING INSTRUMENTS - A-OK |
MDA/FCA/P0902-42542536-2024 |
GB64940468817 |
ALCON LABORATORIES (M) SDN. BHD. YAP EE PENG |
|
17 |
26/07/2024 |
Potential Sharpness Issues with Specific Ophthalmic Knives and Trocar Entry Systems |
CUSTOM PAK: MAL-PHACO (SUNWAY MEDICAL CENTRE) |
MDA/FCA/P0903-71132649-2024 |
GB14857931018 |
ALCON LABORATORIES (M) SDN. BHD. YAP EE PENG |
|
18 |
26/07/2024 |
Increased complaints related to sharpness for specific ophthalmic knives |
CONSTELLATION VISION SYSTEM |
MDA/FCA/P0904-33189228-2024 |
GC96073327017 |
ALCON LABORATORIES (M) SDN. BHD. YAP EE PENG |
|
19 |
26/07/2024 |
XPERT BCR-ABL ULTRA |
MDA/FCA/P0905-70923499-2024 |
IVDC74609321918 |
SPD SCIENTIFIC (M) SDN. BHD. HOR ZIAN KHANG |
|
|
20 |
26/07/2024 |
VITROS IMMUNOCHEMISTRY ANEMIA |
MDA/FCA/P0907-36964023-2024 |
IVDB4526523-139948 |
T T MEDICAL MANAGEMENT SDN BHD MENG TSE LEEAU |
|
|
21 |
26/07/2024 |
Access HBC Ab reagent kit may contain an unusual amount of PMP clumping at the top of Well 0. |
ACCESS HBC AB |
MDA/FCA/P0908-60574603-2024 |
IVDD3300676017 |
BECKMAN COULTER MALAYSIA SDN. BHD. ONG NGUAN CHING |
|
22 |
29/07/2024 |
RAPIDPOINT 500 |
MDA/FCA/P0909-75051084-2024 |
IVDC6984796818 |
SIEMENS HEALTHCARE SDN. BHD. FRAZER RODERICK JOHN |
|
|
23 |
29/07/2024 |
AUTOMATED HEMATOLOGY ANALYZER XN-31 |
MDA/FCA/P0910-96311095-2024 |
IVDC10764424-170755 |
SYSMEX (MALAYSIA) SDN. BHD. CHEAH KIT YIN |
