Thera Test Laboratories, Inc. recalls EL-Anti-SARS-CoV-2 IgG Kit, Catalog #104-130. Submitted as EUA202128
- Recall date
- October 5, 2020
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-2382-2021
- FDA classification
- Class II
- Brand / firm
- Thera Test Laboratories, Inc.
- Sold / distributed
- US Nationwide distribution in the states of California, Florida, Illinois, Indiana, North Carolina, and Texas.
Why it was recalled
The cross-reactivity of the device may present an increased level of potential false positives. Submitted as EUA202128
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
EL-Anti-SARS-CoV-2 IgG Kit, Catalog #104-130. Submitted as EUA202128
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