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Type of Product Medical Device
TGA Recall Reference RC-2014-RN-00293-1
Product Name/Description FB Reagent, ZYM B Reagent, API Listeria and API NH

FB Reagent
Reference Number: 70562

ZYM B reagent
Reference Number: 70493

Reference Number: 10400

API Listeria
Reference Number: 10300

Multiple lot numbers affected
Recall Action Level Hospital
Recall Action Classification Class II
Recall Action Commencement Date 13/03/2014
Responsible Entity Biomerieux Australia Pty Ltd
Reason/Issue During the Quality Control of new lot of FB reagent, a visual defect (colour issue) was observed. The first investigation performed by the manufacturing site showed that this visual defect is due to a specific lot of raw material used for the manufacturing of this FB reagent. In addition, this lot of raw material has also been used for the manufacturing of several lots of FB reagent and ZYM B reagent using the same raw material than the FB reagent. As the involved lots of ZYM B reagent are included inside of API NH and API Listeria kits, the both references are also impacted.
Recall Action Recall for Product Correction
Recall Action Instructions BioMeriuex is requesting their customers to discontinue use and discard any stock with visual defects. Testing using the affected lost can continue if daily QC is run using a validated ATCC strain.
Contact Information 1800 333 421 - bioMerieux Technical Assistance Department