| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2014-RN-01342-1 |
| Product Name/Description |
PF4 IgG assay (Thrombophilia and coagulation inhibitor assay). An in vitro Diagnostic Medical Device (IVD).
Lot Numbers: 3001992 & 3002227
ARTG Number: 217308 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
19/12/2014 |
| Responsible Entity |
|
| Reason/Issue |
The manufacturer has determined that the PF4 concentrated wash (10x) lots indicated in this letter were manufactured at a slightly more dilute concentration. This may result in slightly increased Optical Density (positive bias) values with results generated using these buffer lots. |
| Recall Action |
Recall |
| Recall Action Instructions |
Diagnostic Solutions is requesting their customers to discard the affected kits. Replacement reagents will be provided. This action has been closed-out on 14/07/2016. |
| Contact Information |
1300 788 003 - Diagnostic Solutions Customer Service |