Thera Test Laboratories EL-Anti-SARS-CoV-2 IgM Kit, Catalog #104-129, IVD recall — FDA Z-2381-2021
Device did not meet the updated EUA packet requirements for positive percent agreement, thus, not adequately validated. Submitted as EUA202129
Overview of recall records associated with Thera Test Laboratories, Inc., including dates, categories and classifications where available.
Classification mix: Class II: 1.
Device did not meet the updated EUA packet requirements for positive percent agreement, thus, not adequately validated. Submitted as EUA202129
This page summarizes recall records in which the official source identifies Thera Test Laboratories, Inc. as the recalling firm or manufacturer. The number of records should not be treated as a safety rating or a measure of company size, because recall counts depend on product mix, reporting periods and how government records are organized.
Compare the dates, categories and classifications together rather than relying on the total alone. Open an individual record for the recalled product, reason, distribution details and current instructions available from the source.