The Recall Desk
HighFDA (Devices)·Z-2382-2021·Announced 2021-09-08

FDA Recalls COVID-19 Antibody Test Kits for Increased False Positive Risk

Thera Test Laboratories is recalling EL-Anti-SARS-CoV-2 IgG kits due to cross-reactivity that may produce false positive results. The recalled lot numbers are 05204351 and 05204368, affecting distribution in six US states.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: FDA Class II medical device with theoretical risk of false positive results from cross-reactivity, but no reported illnesses or injuries. Per the severity rubric, this qualifies as a risk-of-harm product where injury has not yet been reported.

Plain-English summary

Thera Test Laboratories, Inc. has recalled 19 units of the EL-Anti-SARS-CoV-2 IgG Kit (Catalog #104-130) due to increased potential for false positive results. The U.S. Food and Drug Administration classified this as a Class II recall. The affected lot numbers are 05204351 (expiration 5/1/2021) and 05204368 (expiration 05/19/2021).

The device's cross-reactivity may produce false positive test results. The recalled units were distributed nationwide in California, Florida, Illinois, Indiana, North Carolina, and Texas.

Patients and healthcare providers who have used these kits should be aware of this recall due to the potential for false positive results.

The recalled product

Product
EL-Anti-SARS-CoV-2 IgG Kit, Catalog #104-130. Submitted as EUA202128
Manufacturer
Thera Test Laboratories, Inc.
Category
Medical Device — Diagnostic Test
Hazard
  • false-positive
  • cross-reactivity

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (4)

  • Lot numbers 05204351
  • exp. 5/1/2021
  • and 05204368
  • exp. 05/19/2021.

Distribution

Distributed nationwide across the United States.

Related recalls

Same category