| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2018-RN-00318-1 |
| Product Name/Description |
ID-Cards for Indirect Antiglobulin Testing associated with Reagent Red Blood Cells. An in vitro diagnostic medical device (IVD).
LISS/Coombs, Coombs Anti-IgG, DiaScreen, LISS/Coombs + Enzyme Test, and DiaClon Type + Screen
Product ID Numbers: 50531, 50540, 50571, 50581,50682
Multiple Catalogue and Lot Numbers
ARTG Number: 212527
(Bio-Rad Laboratories - Multiple blood grouping and typing IVDs) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
20/04/2018 |
| Responsible Entity |
|
| Reason/Issue |
Bio-Rad Laboratories have been able to confirm an increased level of Antibody of Undetermined Specificity (AUS) when using some reagents of the ID-System intended for irregular antibody screening and identification. |
| Recall Action |
Product Defect Correction |
| Recall Action Instructions |
BioRad is advising that the capacity of impacted lots of ID-Cards to detect and identify clinically significant antibodies is not affected by this issue. For that reason users may continue to use these products for their intended purpose. In the event users experience an AUS level impacting the ability to render final results, users should consider using an alternative method such as the tube method to verify results.
This action has been closed out on 21/11/2018 |
| Contact Information |
1800 224 354 - Bio-Rad Laboratories |