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FDAJuly 30, 2020device

EL-Anti-SARS-CoV-2 IgM Kit, Catalog #104-129, IVD. Submitted as EUA202129

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

The hazard

Device did not meet the updated EUA packet requirements for positive percent agreement, thus, not adequately validated. Submitted as EUA202129

What to do

FDA enforcement status: Terminated

Brands named

thera test laboratoriestherathera test

Recall history

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

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