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Type of Product Medical Device
TGA Recall Reference RC-2017-RN-00470-1
Product Name/Description ETEST ETP32 (Ertapenem) WW B30. An in vitro diagnostic medical device (IVD) for Antimicrobial susceptibility testing.

Reference Number: 531600

Multiple Lot Numbers

ARTG Number:187139
Recall Action Level Hospital
Recall Action Classification Class II
Recall Action Commencement Date 8/05/2017
Responsible Entity Biomerieux Australia Pty Ltd
Reason/Issue A bioMérieux investigation has confirmed a potential performance issue on strain categorization for Streptococcus viridans group and Streptococcus pneumoniae based on 2017 CLSI and EUCAST breakpoints, which could lead to False Susceptible result instead of resistant results on ETEST ETP32 blister packaging when comparing to the Broth-Micro Dilution (BMD) reference method.
Recall Action Recall for Product Correction
Recall Action Instructions bioMérieux is advising customers who use the 2017 CLSI and 2017 EUCAST clinical guidelines that they can continue the use of ETEST ETP32 blister packaging except for Streptococci group including S. pneumoniae strains. bioMérieux is also advising that laboratories should identify any possible false Susceptible results from previously performed tests and analyse the related risks and determine appropriate actions if relevant.

This action has been closed out on 14/11/2018
Contact Information 1800 333 421 - bioMérieux Help Desk Department