Product Wiki · Recalls · Health Canada — Medical Devices

Enterococcus Faecalis Derived from ATCC 51299 (2020-02-21) — recall 63287

Health Canada — Medical Devices · Canada · 2020-04-15 · Type III

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Agency
Health Canada — Medical Devices
Recall identifier
63287
Date of alert
2020-04-15
Country / jurisdiction
Canada
Authority classification
Type III
Notice type
recall
Product category
Medical devices
Product type
Medical devices
Reported risk: High level gentamicin synergy value was out of specification (sensitive) when analyzed on the vitek 2 AST-GP67 card, and these lots also failed the disk diffusion method used for product release.
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/enterococcus-faecalis-derived-

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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