| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2018-RN-00507-1 |
| Product Name/Description |
MIA FORA NGS FLEX 11 HLA Typing Kit. An in vitro diagnostic medical device (IVD).
Product Number: TL-SR-800-10433-24
Lot Number: 18-299-11-C
ARTG Number: 288368
(Abacus dx - Multiple human leukocyte antigens (HLA) typing IVDs) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class III |
| Recall Action Commencement Date |
14/05/2018 |
| Responsible Entity |
|
| Reason/Issue |
Abacus have been notified by the manufacturer, BioArray Solutions, that Lot # 18-299-11-C contains a subassembly kit (MIA FORA NGS FLEX HLA PCR Kit 2 (Lot 18-299)) with an incorrect expiration date of 2109-04-30 instead of 2019-04-30.
No other subassemblies within Lot 18-299-11-C are impacted and no other MIA FORA NGS FLEX 11 HLA Typing Kit lot numbers are affected. |
| Recall Action |
Product Defect Correction |
| Recall Action Instructions |
Abacus is requesting users to identify impacted product and correct the PCR kit 2 expiry date to 2019.
This action has been closed out on the 26/11/2018. |
| Contact Information |
1800 222 287 - Abacus |