Product Wiki · Recalls · Health Canada — Medical Devices

Architect I System – Testosterone Assay — recall 48865

Health Canada — Medical Devices · Canada · 2013-02-04 · Type III

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Agency
Health Canada — Medical Devices
Recall identifier
48865
Date of alert
2013-02-04
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: Missing product safety information – the current labels and package inserts for the Architect Testosterone Reagent: ln 7K73-20 and 7K73-25, Architect Testosterone Calibrators; ln 7K73-01 and Architect Testosterone Controls; In 7K73-10 do not contain the warnings and precautions applicable to material containing methylisothiazolones which are classified as skin sensitizers.
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/architect-system-testosterone-

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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