Product Wiki · Recalls · Health Canada — Medical Devices

Anti-Human Globulin Anti-IgG (Rabbit) MTS Anti-IgG Card — recall 56234

Health Canada — Medical Devices · Canada · 2017-02-28 · Type III

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Agency
Health Canada — Medical Devices
Recall identifier
56234
Date of alert
2017-02-28
Country / jurisdiction
Canada
Risk level
Type III
Risk type
recall
Product category
Medical devices
Product type
Medical devices
Notice status
Archived by the issuing authority — kept for reference
Reported risk: Ortho Clinical Diagnostics (Ortho) has initiated a recall due to the potential for false positive reactions when using specific lots of anti-human globulin Anti-IgG (rabbit) MTS Anti-IgG cards (MTS Anti-IgG cards). It has been determined that affected MTS Anti-igg card lots may exhibit a varying low-level activity of anti-complement that may result in a false positive test.
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/anti-human-globulin-anti-igg-r

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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