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FDAOctober 1, 2020device

EDI Novel Coronavirus COVID-19 IgG ELISA Kit, REF: KT-1032 Per label: This kit is intended for qualitative detection of human anti-COVID-19 IgG antibody in human serum. This kit is to be used as an aid for the detection of novel COVID-19. Patients with suspected clustering cases require diagnosis...

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

The hazard

The use of deionized water rather than distilled water during the manufacturing process, may have resulted in accelerated decreased OD signals for the Positive Control value.

What to do

FDA enforcement status: Ongoing

Brands named

epitope diagnosticsepitope

Recall history

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

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