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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 Bio-Rad Laboratories Pty Ltd
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