Print version of this report
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