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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 API NH 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