Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
EL-Anti-SARS-CoV-2 IgM Kit Recalled by Thera Test Laboratories, Inc. Due to Device did not meet the updated EUA packet...
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 IgM Kit, Catalog #104-129, IVD. Submitted as EUA202129
Quantity: 11 kits
Why Was This Recalled?
Device did not meet the updated EUA packet requirements for positive percent agreement, thus, not adequately validated. Submitted as EUA202129
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Thera Test Laboratories, Inc.
Thera Test Laboratories, Inc. has 2 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report