Product Wiki · Recalls · Health Canada — Medical Devices

Anti-Lua (Lu1) — recall 64043

Health Canada — Medical Devices · Canada · 2022-07-11 · Type II

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Agency
Health Canada — Medical Devices
Recall identifier
64043
Date of alert
2022-07-11
Country / jurisdiction
Canada
Risk level
Type II
Risk type
recall
Product category
Haematology
Product type
Medical devices
Reported risk: A recall was issued in connection to false negative results for the Anti-Lua control (Lu 1) from lot 3113160-00, because minimum antibody levels were not met. The two lots (3131020-00 and 3131030-00) produced to replace lot 3113160-00 have shown a decrease in reactivity over their life of approximately nine months. Soon, the acceptance criteria may no longer be met. Therefore, these lots are also being recalled. Recall start date: Mar 22, 2022
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/anti-lua-lu1

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