Etest COLISTIN CO 256 WWEtest COLISTIN CO 256 WW B30 의 리콜

Recall

RC-2016-RN-01008-1

Class I

2016-07-29

Australia

DHTGA

https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-01008-1

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).

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.