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Type of Product	Medical Device
TGA Recall Reference	RC-2014-RN-00159-1
Product Name/Description	Etest Ertapenem Foam and Single Blister Packs (antibiotic susceptibility test). An in vitro diagnostic medical device (IVD) Product Reference Number:531618 Lot Number: 1002054430 Reference /Lot Number inside packaging: 51103168, 1001897090 Product Reference Number: 531610 Lot Number: 1000853690, 1001960650 Reference /Lot Number inside packaging: 51103610, 1001895910, 51103160, 1001895910 Product Reference Number: 412332 Lot Number: 1002110560, 1002389880 ARTG Number: 187139
Recall Action Level	Hospital
Recall Action Classification	Class II
Recall Action Commencement Date	13/02/2014
Responsible Entity	Biomerieux Australia Pty Ltd
Reason/Issue	bioMérieux has identified that the affected Etest strips do not give the correct Minimum Inhibitory Concentration (MIC) for some Quality Control strains, with the MIC results out of range (high) according to the MIC specification described in the Quality Control procedure. The MIC results conformed at the time of batch release however investigations have confirmed this issue appears over time, leading to a performance issue by overestimating the MIC.
Recall Action	Recall
Recall Action Instructions	bioMerieux is advising users to discontinue use and destroy affected stock. Replacement kits will be provided once a new batch is available.
Contact Information	1800 333 421 - bioMerieux Technical Assistance Department