| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2016-RN-00117-1 |
| Product Name/Description |
Anti-Jk (Jk1).
Catalogue Number: 808176
Lot Number: 2515080-00
Expiry Date: 30-03-2017
ARTG Number: 250456
An in vitro diagnostic medical device (IVD) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
2/02/2016 |
| Responsible Entity |
|
| Reason/Issue |
This product showed a reactivity decrease after approximately 9 months shelf life. Weak or false negative results may be possible in testing.
A false negative result of Jka antigen detection of a donor sample, can lead to a Hemolytic Transfusion Reaction (HTR) of Jka negative recipient after transfusion.
or a delay in testing. |
| Recall Action |
Recall |
| Recall Action Instructions |
Bio-Rad is advising users to inspect stock and quarantine the affected units prior to their return. |
| Contact Information |
1800 224 354 - Bio-Rad |