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Type of Product	Medical Device
TGA Recall Reference	RC-2012-RN-01049-1
Product Name/Description	ChromID Strepto B agar (Used for screening of S. agalactiae carriage in pregnant women and potential infections in newborns). An in-vitro diagnostic medical device (IVD) Batch Number: 1001508710 Reference Number: 43461
Recall Action Level	Hospital
Recall Action Classification	Class II
Recall Action Commencement Date	16/10/2012
Responsible Entity	Biomerieux Australia Pty Ltd
Reason/Issue	The investigations performed by BioMerieux Quality Control laboratory after receiving customer complaints have confirmed a sensitivity issue for the affected batch. BioMerieux cannot guarantee the characteristic colouration of the Streptococcus B colonies at 24 hours and 48 hours of incubation.
Recall Action	Recall
Recall Action Instructions	Discontinue use and discard affected stock. Biomerieux Australia will provide a credit note or replace the affected lots.
Contact Information	1800 333 421 - Biomerieux Technical Assistance Department