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Vitek MS — recall 48479

Health Canada — Medical Devices · Canada · 2012-11-26 · Type III

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Agency: Health Canada — Medical Devices
Recall identifier: 48479
Date of alert: 2012-11-26
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: The currently available knowledgebase, Vitek MS Version 2.0, is known to have lower performance for the nine (9) mycobacteria species listed in the knowledgebase user manual supplement. Additionally, an internal study determined that in rare circumstances the current mycobacteria protocol might not completely inactivate multi drug resistant (MDR) M. tuberculosis when using 30/70 TFA/ETOH (trifluoroacetic/ethanol).

Primary source: https://recalls-rappels.canada.ca/en/alert-recall/vitek-ms

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Vitek MS — recall 48479

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