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Type of Product Medical Device
TGA Recall Reference RC-2014-RN-01000-1
Product Name/Description NaCl, Enzyme Test and Cold Agglutinins

ID Number: 50520

Reference Numbers: 005014 / 005015 / 005016

Batch number : 50520.93.09 with expiry 2016.01

ARTG Number: 217697
Recall Action Level Hospital
Recall Action Classification Class II
Recall Action Commencement Date 16/09/2014
Responsible Entity Bio-Rad Laboratories Pty Ltd
Reason/Issue During an internal investigation, the manufacturer determined that well number 3 of ID card NaCl, Enzyme Test and Cold Agglutinins of the affected lot may contain on a random basis a very small amount of monoclonal anti-E (anti-RH3).
Recall Action Recall
Recall Action Instructions Bio-Rad is advising users to destroy any remaining affected units if unaffected lots of product are available. As an interim measure, if another lot is not immediately available it is possible to use lot 50520.93.09 with particular attention to the interpretation of positive results:
- By manual method, do not use well 3 of the card.
- On the automated method, if a positive result is obtained in well 3, use the manual method following the instruction above. This action has been closed-out on 03/06/2016.
Contact Information 1800 224 354 - Bio-Rad Laboratories