| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2014-RN-01000-1 |
| Product Name/Description |
NaCl, Enzyme Test and Cold Agglutinins
ID Number: 50520
Reference Numbers: 005014 / 005015 / 005016
Batch number : 50520.93.09 with expiry 2016.01
ARTG Number: 217697 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
16/09/2014 |
| Responsible Entity |
|
| Reason/Issue |
During an internal investigation, the manufacturer determined that well number 3 of ID card NaCl, Enzyme Test and Cold Agglutinins of the affected lot may contain on a random basis a very small amount of monoclonal anti-E (anti-RH3). |
| Recall Action |
Recall |
| Recall Action Instructions |
Bio-Rad is advising users to destroy any remaining affected units if unaffected lots of product are available. As an interim measure, if another lot is not immediately available it is possible to use lot 50520.93.09 with particular attention to the interpretation of positive results:
- By manual method, do not use well 3 of the card.
- On the automated method, if a positive result is obtained in well 3, use the manual method following the instruction above. This action has been closed-out on 03/06/2016. |
| Contact Information |
1800 224 354 - Bio-Rad Laboratories |