Print version of this report
Type of Product Medical Device
TGA Recall Reference RC-2016-RN-01008-1
Product Name/Description Etest COLISTIN CO 256 WW. An in vitro diagnostic medical device (IVD)

Etest COLISTIN CO 256 WW B30
Catalogue Number: 537300

Etest COLISTIN CO 256 WW B100
Catalogue Number: 537308

Multiple Lot Numbers

ARTG Number: 187139
Recall Action Level Hospital
Recall Action Classification Class I
Recall Action Commencement Date 29/07/2016
Responsible Entity Biomerieux Australia Pty Ltd
Reason/Issue bioMérieux has been alerted via a European Committee on Antimicrobial Susceptibility Testing (EUCAST) warning letter about potential underestimation of the Minimum Inhibitory Concentration (MIC) values for Enterobacteriaceae and Acinetobacter when using the Etest COLISTIN gradient test. There is potential to obtain False Susceptible results.

bioMérieux have initiated a complaint investigation. The investigations are on-going, with the following identified to date:

- Etest COLISTIN performance depends on the Mueller Hinton agar plate used.

- For Enterobacteriaceae strains, the performance conforms if used in conjunction with the MHE agar (from bioMérieux) with a good concordance rate compared to Broth-Micro Dilution method.

- There is a potential of False Susceptible results on Etest COLISTIN with some Mueller Hinton agar (except with the MHE agar from bioMérieux for the Enterobacteriaceae strains).
Recall Action Recall for Product Correction
Recall Action Instructions bioMérieux is advising users that for Enterobacteriaceae strains, to can continue to use Etest COLISTIN for diagnostic purposes, only if it is used with MH-E agar (Mueller Hinton-E agar from bioMérieux Ref. 413822-or the soon to be launched 04091 MHE agar in October 2016)). If not, or if strains other than Enterobacteriaceae are tested, bioMérieux recommend users restrict its use to epidemiological surveys.

Among tests previously performed, it is recommended users identify any possible false Susceptible results, analyse the related risks and determine appropriate actions if relevant.

This action has been closed out on 13/08/2019
Contact Information 1800 333 421 - bioMérieux Technical Assistance Department