Thera Test Laboratories, Inc. recalls EL-Anti-SARS-CoV-2 IgM Kit, Catalog #104-129, IVD. Submitted as EUA202129
- Recall date
- July 30, 2020
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-2381-2021
- FDA classification
- Class II
- Brand / firm
- Thera Test Laboratories, Inc.
- Sold / distributed
- US Nationwide distribution in the states of CA, FL, IL, IN, NC, and TX.
Why it was recalled
Device did not meet the updated EUA packet requirements for positive percent agreement, thus, not adequately validated. Submitted as EUA202129
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 IgM Kit, Catalog #104-129, IVD. Submitted as EUA202129
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