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Type of Product Medical Device
TGA Recall Reference RC-2017-RN-00241-1
Product Name/Description Various ID-Diacell Products. An in vitro diagnostic medical device (IVD).

ID-DiaCell Pool
ID-DiaCell I-II
ID-DiaCell I-II-III Asia
ID-DiaScreen Prophylax
ID-DiaPanel Plus 6
ID-DiaCell ABO
ID-DiaCell lP-llP-lllP

Multiple Catalogue Numbers

All unexpired lots

ARTG Number: 213161
Recall Action Level Hospital
Recall Action Classification Class II
Recall Action Commencement Date 28/02/2017
Responsible Entity Bio-Rad Laboratories Pty Ltd
Reason/Issue Bio-Rad has identified an issue in relation to unexpected reactions primarily on eluates and QC samples but also with some patient samples when using ID-Diacell products. There is the potential for false positive results.
Recall Action Recall for Product Correction
Recall Action Instructions Bio Rad Laboratories is advising users to re-test with a new kit if they are doubtful of the results and if doubts remain after re-testing, to use an alternative testing method. Users are further advised to disseminate this information to relevant personnel within their facilities.
This action has been closed-out on 21/03/2018.
Contact Information 1800 224 354 - Bio-Rad Laboratories