Thera Test Laboratories, Inc. recalls EL-Anti-SARS-CoV-2 IgM Kit, Catalog #104-129, IVD. Submitted
Recalled Product
EL-Anti-SARS-CoV-2 IgM Kit, Catalog #104-129, IVD. Submitted as EUA202129
Hazard / Issue
Device did not meet the updated EUA packet requirements for positive percent agreement, thus, not adequately validated. Submitted as EUA202129
Issued by
FDA
Distribution: Nationwide (United States)
Lot/Code Info: Kit lot numbers 05204350, exp. 05/01/2021; 05204367, exp. 05/19/2021; and 06204432, exp. 05/19/2021.
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