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Health Canada Medical devices

Anti-GM1 Autoantibodies Elisa IVD Test

Issued September 20, 2022
Issue
Errancy of the microtiter plate of Anti-GM1 autoantibodies kit lot 0461 during production. False positive or false negative results may occur. Due to the production with non-validated microtiter plate, this risk can be increased with kit lot 0461. To prevent this risk, the kit must be removed from the market. Recall start date: September 5, 2022
Hazard description
Performance
Product
Product name
Anti-GM1 Autoantibodies Elisa IVD Test
Reference
ID
RA-64560