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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 Bio-Rad Laboratories Pty Ltd
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