Product Wiki · Recalls · Health Canada — Medical Devices

Vitek MS-CHCA Matrix and Vitek MS-DS Target Slides (2014-02-27) — recall 51485

Health Canada — Medical Devices · Canada · 2014-04-04 · Type III

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Agency
Health Canada — Medical Devices
Recall identifier
51485
Date of alert
2014-04-04
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: It has been confirmed that one of the positive QC strains, Enterococcus faecalis ATCC 19433, was not reproducible when tested on Vitek MS following culture on the Trypcase Soy Agar + 5% sheep blood (TSS) media. During development, this Enterococcus faecalis ATCC 19433 strain was tested after culture on the Colombia Agar + 5% sheep blood media. Therefore, the culture of this strain on the Trypcase Soy Agar + 5% sheep blood (TSS) media was never validated.
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/vitek-ms-chca-matrix-and-vitek

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