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Thera Test Laboratories, Inc.

Thera Test Laboratories, Inc. Recalls

All product recalls associated with Thera Test Laboratories, Inc..

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Recall Summary

Total Recalls

Past Year

Class I (Serious)

Most Recent

Oct 2020

Data from FDA, USDA, CPSC, and NHTSA public records. Recall counts vary by company size, industry, and reporting practices. Always check official sources for current information.

Showing 1–3 of 3 recalls

Thera Test Laboratories, Inc.: EL-Anti-SARS-CoV-2 IgG Kit, Catalog #104-130. Submitted a...

The cross-reactivity of the device may present an increased level of potential false positives. Submitted as EUA202128

FDAOct 5, 2020Nationwide• Thera Test Laboratories, Inc.

Thera Test Laboratories, Inc.: EL-Anti-SARS-CoV-2 IgM Kit, Catalog #104-129, IVD. Submit...

Device did not meet the updated EUA packet requirements for positive percent agreement, thus, not adequately validated. Submitted as EUA202129

FDAJul 30, 2020Nationwide• Thera Test Laboratories, Inc.

Thera Test Laboratories, Inc.: EL-aCL Anti-Cardiolipin ELISA Kit; an in-vitro diagnostic...

The specimen diluent contained in the kits was contaminated with a fungal growth. Also, a portion of kit lot 09055514 was shipped without the Data Sheet, part #201-204.

FDA

Jan 11, 2006

CA, CT, FL +4 more

• Thera Test Laboratories, Inc.