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Thera Test Laboratories, Inc. recalls EL-Anti-SARS-CoV-2 IgM Kit, Catalog #104-129, IVD. Submitted as EUA202129
Recalled September 8, 2021 · FDA recall Z-2381-2021 · Thera Test Laboratories
Hazard
Device did not meet the updated EUA packet requirements for positive percent agreement, thus, not adequately validated. Submitted as EUA202129 · FDA Class II
Units
11 kits
Sold at
US Nationwide distribution in the states of CA, FL, IL, IN, NC, and TX.
Description
Device did not meet the updated EUA packet requirements for positive percent agreement, thus, not adequately validated. Submitted as EUA202129
Product
EL-Anti-SARS-CoV-2 IgM Kit, Catalog #104-129, IVD. Submitted as EUA202129
Manufacturer(s)
Thera Test Laboratories, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →