Product Wiki · Recalls · Health Canada — Medical Devices

Enzyme Solution Papain Ortho Sera — recall 73750

Health Canada — Medical Devices · Canada · 2023-06-02 · Type II

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Agency
Health Canada — Medical Devices
Recall identifier
73750
Date of alert
2023-06-02
Country / jurisdiction
Canada
Risk level
Type II
Risk type
recall
Product category
Haematology
Product type
Medical devices
Reported risk: Ortho™ Sera Papain is used to enhance reactivity of Ortho™ Sera red blood cell antigen typing reagents and red blood cells when used in in-vitro immunohematology assays. Through a customer complaint investigation, the reactivity of Ortho™ Sera Papain of the affected lots stated above has been confirmed as reduced. Recall start date: May 19, 2023
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/enzyme-solution-papain-ortho-s

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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