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Type of Product Medical Device
TGA Recall Reference RC-2016-RN-00117-1
Product Name/Description Anti-Jk (Jk1).
Catalogue Number: 808176
Lot Number: 2515080-00
Expiry Date: 30-03-2017

ARTG Number: 250456

An in vitro diagnostic medical device (IVD)
Recall Action Level Hospital
Recall Action Classification Class I
Recall Action Commencement Date 2/02/2016
Responsible Entity Bio-Rad Laboratories Pty Ltd
Reason/Issue This product showed a reactivity decrease after approximately 9 months shelf life. Weak or false negative results may be possible in testing.
A false negative result of Jka antigen detection of a donor sample, can lead to a Hemolytic Transfusion Reaction (HTR) of Jka negative recipient after transfusion.
or a delay in testing.
Recall Action Recall
Recall Action Instructions Bio-Rad is advising users to inspect stock and quarantine the affected units prior to their return.
Contact Information 1800 224 354 - Bio-Rad