| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2024-RN-00144-1 |
| Product Name/Description |
Anti-k. An in vitro diagnostic medical device (IVD)
Catalogue number: 007251
Expiry: 30/09/2024
Product UDI: 07611969001477
ARTG 217696
(Bio-Rad Laboratories Pty Ltd - Immunohaematology blood grouping antisera IVDs) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
22/02/2024 |
| Responsible Entity |
|
| Reason/Issue |
An anomaly has been identified that could pose a risk for patients. It has been detected that the anti-k may result in false positive reactions with k negative samples.
Cases reported thus far have been confirmed during our investigations. False positive reactions up to a “++” reaction may occur. |
| Recall Action |
Product Defect Correction |
| Recall Action Instructions |
Bio-Rad is requesting that customers affected by this notice take the following action in case you obtain reaction = “++” for anti-k well:
- Use alternative method to confirm the result with other reagents available on the market, for example:
o Tube testing with Seraclone Anti-k, Ref 808126, or
o Other reagents intended to the identification of k (KEL2)
Note that Reactions = “+++” are true positives and indicate the presence of k (KEL2) antigen. |
| Contact Information |
1800 224 354 - Bio-Rad Laboratories Technical Support |