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Health Canada Medical devices

Anti-Lua (Lu1)

Issued July 11, 2022
Issue
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
Hazard description
Inaccurate test or measurement results
Product
Product name
Anti-Lua (Lu1)
Reference
ID
RA-64043