Thera Test recalls specific COVID-19 IgM test kits due to potential inaccurate results. The kits may not meet updated EUA requirements for positive percent agreement, leading to unreliable test outcomes.
Device did not meet the updated EUA packet requirements for positive percent agreement, thus, not adequately validated. Submitted as EUA202129
Thera Test is recalling certain COVID-19 IgM test kits because they may not work correctly as required by the FDA. This could lead to inaccurate test results, which might affect whether someone gets the right care.
The test kits did not meet updated FDA requirements for positive percent agreement, meaning they might not detect the virus accurately. This could result in false negatives or false positives, leading to incorrect health decisions.
People who purchased the specific lot numbers of the EL-Anti-SARS-CoV-2 IgM Kit (Catalog #104-129) from the listed expiration dates. Those using the test for home COVID-19 screening are most at risk of getting incorrect results.
Check the kit's lot number on the packaging: 05204350 (expires 05/01/2021), 05204367 (expires 05/19/2021), or 06204432 (expires 05/19/2021). The product is labeled as EL-Anti-SARS-CoV-2 IgM Kit, Catalog #104-129, and is an IVD (in vitro diagnostic) device.
Look for the lot numbers 05204350, 05204367, or 06204432 on the packaging.
The test kits did not meet updated FDA requirements for positive percent agreement, which could lead to inaccurate results.
The recall record does not specify a remedy, so you should check the lot number and contact Thera Test if you have concerns.
The test may not work correctly, leading to false results. However, the recall does not indicate a risk of injury or serious harm.
We’ve drafted a message you can send Thera Test to request your refund or repair — edit it as you like.
Subject: Recall Z-2381-2021 — Thera Test Thera Test Hello, I own a Thera Test that is covered by recall Z-2381-2021 from Thera Test. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
