Product Wiki · Recalls · Health Canada — Medical Devices

Klebsiella Pneumoniae Derived from NCTC 13439 (2020-10-19) — recall 61786

Health Canada — Medical Devices · Canada · 2020-10-30 · Type II

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Agency
Health Canada — Medical Devices
Recall identifier
61786
Date of alert
2020-10-30
Country / jurisdiction
Canada
Risk level
Type II
Risk type
recall
Product category
Medical devices
Product type
Medical devices
Reported risk: A complaint investigation identified that the lot numbers listed above do not contain the VIM-1 gene and are not metallo beta-lactamase positive. Identification of the loss of the VIM-1 gene was confirmed via Verigene Gram-Negative Blood Culture Nucleic Acid Test, metallo beta-lactamase (MBL) IP/IPI Etest and mCIM/eCIM testing. If this product is not used specifically for VIM-1/metallo beta-lactamase detection there will be no impact on the results.
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/klebsiella-pneumoniae-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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