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FDAOctober 5, 2020device

EL-Anti-SARS-CoV-2 IgG Kit, Catalog #104-130. Submitted as EUA202128

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

The hazard

The cross-reactivity of the device may present an increased level of potential false positives. Submitted as EUA202128

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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