Anti-gm1 Autoantibodies Elisa Ivd Test

Recall Summary The Anti-GM1 Autoantibodies Elisa IVD Test, a diagnostic laboratory test used to detect certain autoimmune antibodies, is being recalled across Canada due to performance issues with the test. This Class I recall affects healthcare providers and laboratories that use this test to help diagnose conditions related to anti-GM1 autoantibodies. The recall was issued because the test may not perform as intended.

Product
Anti-GM1 Autoantibodies Elisa IVD Test
Reason
Performance
Classification
Class I
Category
drug recall
Country
Canada
Agency
HC-DEVICES
Recall date
2022-09-20
Status
Ongoing
Distribution
Canada-wide

Official recall notice from HC-DEVICES

Recall details on Nibble Recalls: https://trynibble.app/recalls/1982fa49-0a9c-4b73-956a-26e5deb3f0c0