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FDAMarch 17, 2021device

Trinity Biotech Captia Measles IgM Kit, Catalog No. 2326060 - Product Usage: intended for the qualitative detection of Measles igM antibodies in human serum of patients suspected of measles (rubeola) infection.

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

Positive Control may run high out of its assigned ISR range and result in an invalid run and necessitate retesting

What to do

FDA enforcement status: Terminated

Brands named

clark laboratoriesclark

UPCs

05391516743655

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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