| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2017-RN-01491-1 |
| Product Name/Description |
MIA FORA NGS HLA FLEX 11 KIT (24 tests). An in vitro diagnostic medical device (IVD)
Lot Number: 18-107-11-C
ARTG Number: 288368 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
6/12/2017 |
| Responsible Entity |
|
| Reason/Issue |
Diagnostic Solutions has been made aware by the manufacturer, BioArray Solution, that a limited number of MIA FORA NGS HLA FLEX 11 KIT (24 tests) CE kits Lot 18- 107-11-C contain Index Adaptor Plates (IAP) P/N SR-800-00349, Lot 18-30A that may result in incorrect calls for samples in the F1 and G1 plate positions due to switched barcode adaptors in positions F1 and G1.
The impact of a defective IAP when used for testing will result in the wrong call at plate positions F1 and G1 and therefore an incorrect result. |
| Recall Action |
Recall |
| Recall Action Instructions |
Diagnostic Solutions is advising customers to quarantine all units of Lot 18-107-11-C from inventory. Diagnostic Solutions will confirm with users whether any of their stock is defective and will arrange for replacement of defective units. Diagnostic Solutions recommend that all F1 and G1 sample results generated with the MIA FORA NGS HLA FLEX 11 KIT (24 tests) Lot 18-107-11-C are retested to confirm samples have been correctly identified.
This action has been closed out on the 16/10/2018. |
| Contact Information |
1300 788 003 - Diagnostic Solutions |