Product Wiki · Recalls · Health Canada — Medical Devices

Softwares for VITEK Systems (2015-02-17) — recall 53178

Health Canada — Medical Devices · Canada · 2015-05-21 · Type III

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Agency
Health Canada — Medical Devices
Recall identifier
53178
Date of alert
2015-05-21
Country / jurisdiction
Canada
Risk level
Type III
Risk type
recall
Product category
Medical devices
Product type
Medical devices
Notice status
Archived by the issuing authority — kept for reference
Reported risk: VITEK 2 7.01 software introduced a feature (enable - convention for highest reportable MIC) that can be used to modify the 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 as well as AES functionality related to recommended guidelines. When "enabled - convention for highest reportable 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.
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/softwares-vitek-systems-2015-0

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