| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2016-RN-00492-1 |
| Product Name/Description |
ID-Papain Assay. An in vitro diagnostic medical device (IVD)
Catalogue Number: 005510
Lot Numbers:
06311.53.1 (Expiry date 25/04/2016)
06311.54.1 (Expiry date 09/05/2016)
06311.55.1 (Expiry date 23/05/2016)
ARTG Number: 217697 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
29/04/2016 |
| Responsible Entity |
|
| Reason/Issue |
Following customer complaints, Bio-Rad has been able to confirm that the affected lots show a decrease in enzymatic activity, leading to false negative or false positive results. Bio-Rad is recalling the lots identified. This recall is being conducted as a precautionary measure.
A risk assessment has been carried out and revealed that difficulty in interpretation of the results involving identification, auto-control and cross-matching in the enzyme technique may be experienced which may result in a delay in transfusion. |
| Recall Action |
Recall |
| Recall Action Instructions |
Bio-Rad is advising customers to destroy remaining units of the affected lots, and is recommending using ID-Diluent as an alternative. This action has been closed-out on 03/02/2017. |
| Contact Information |
1800 224 354 - Bio-Rad Laboratories |