VITEK 2 system version 7.01. An in vitro diagnostic medical device (IVD) 의 리콜

Recall

RC-2015-RN-00132-1

Class III

2015-02-18

Australia

DHTGA

https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00132-1

Vitek 2 software ver. 7.01 introduced a feature (enable > convention for highest reportable mic) which can be used to modify the ast (antimicrobial susceptibility testing) reporting convention when an ast result is within the highest reportable mic range. advanced expert system (aes) parameter sets are configurable in the vitek 2 software to allow users to select mic breakpoint interpretation.The enable > convention for highest reportable minimum inhibitory concentration (mic) configuration option modifies the highest reportable mic value for each specific antimicrobial to half its doubling dilution and displays the value with a > (greater than) symbol. for example, =32 (highest reportable mic) would be modified to >16 which are equivalent for mic testing.Patient isolates function as intended; however, the software does not recognise the two values (e.G. =32 vs. >16) as equivalent, and incorrectly flags the modified value as a deviation.

Biomeriux is requesting their customers that in the event of a QC deviation for one or more of the ATCC strains and antibiotics indicated, to compare the reported MIC value to the expected MIC value. If the values are equivalent, the deviation is subject to the software discrepancy and can be ignored. This issue will be corrected in software release 8.01 This action has been closed-out on 09/08/2016.