Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

EL-Anti-SARS-CoV-2 IgG Kit Recalled by Thera Test Laboratories, Inc. Due to The cross-reactivity of the device may present an...

Date: October 5, 2020
Company: Thera Test Laboratories, Inc.
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Thera Test Laboratories, Inc. directly.

Affected Products

EL-Anti-SARS-CoV-2 IgG Kit, Catalog #104-130. Submitted as EUA202128

Quantity: 19 kits

Why Was This Recalled?

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

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Thera Test Laboratories, Inc.

Thera Test Laboratories, Inc. has 2 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report