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Type of Product Medical Device
TGA Recall Reference RC-2015-RN-00516-1
Product Name/Description CEFOTAXIME CT 256 WW F100. An in vitro diagnostic medical device (IVD)

Serial Number: 1002774320

ARTG Number: 187139
Recall Action Level Hospital
Recall Action Classification Class II
Recall Action Commencement Date 16/06/2015
Responsible Entity Biomerieux Australia Pty Ltd
Reason/Issue An internal investigation identified a performance deviation associated with Quality Control testing of retained product samples. The QC results were out of range resulting in false resistant strains.
Recall Action Recall
Recall Action Instructions BioMerieux is requesting their customers to discontinue using and discard any remaining inventory of Etest CEFOTAXIME CT 256. This action has been closed-out on 18/08/2016.
Contact Information 1800 333 421 - Technical Assistance