Lower riskMedical device recall · FDA · Published July 30, 2020
Thera Test EL-Anti-SARS-CoV-2 IgM Kit: Inaccurate COVID-19 Test Results
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
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Contact the company
📍Recalling firmThera Test Laboratories, Inc.1120 N Du Page Ave · Lombard, IL 60148-1247
✎ GovInfoNow plain-language explainer
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. Read more at govinfonow.com/recall/64586-thera-test-el-anti-sars-cov-2-igm-kit-inaccurate.
“Thera Test EL-Anti-SARS-CoV-2 IgM Kit: Inaccurate COVID-19 Test Results.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/64586-thera-test-el-anti-sars-cov-2-igm-kit-inaccurate. Based on FDA recall #Z-2381-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2381-2021%22&limit=1).
Thera Test Laboratories, Inc. recalled the EL-Anti-SARS-CoV-2 IgM Kit on July 30, 2020, according to the FDA. The device did not meet updated EUA requirements for positive percent agreement.
Distribution: US Nationwide in CA, FL, IL, IN, NC, and TX
The hazard
The device did not meet the updated EUA packet requirements for positive percent agreement, thus, not adequately validated.
Context
GovInfoNow's records show Thera Test Laboratories, Inc. has 1 other recall on record since 2020-10-05. On 2020-10-05, the company recalled the EL-Anti-SARS-CoV-2 IgG Kit due to false positive risk. Other recent recalls of similar products include Roche Elecsys Anti-TSHR Assay Recall (2025-11-21), Diagnostica Stago Asserachrom HPIA Kit Recall (2025-12-15), and Aniara Diagnostica ZYMUTEST HIA IgG Kit Recall (2026-04-01).
How to tell if you have this one
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.
Brand
Thera Test
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Kit Lot Number
Look for the lot numbers 05204350, 05204367, or 06204432 on the packaging.
Where it went and when
Where it was distributed
Distributed nationwide; the notice names 6 states.
Named in the notice
Covered by “nationwide”
Not listed
FDA distribution: “US Nationwide distribution in the states of CA, FL, IL, IN, NC, and TX.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: California, Florida, Illinois, Indiana, North Carolina, Texas.
Recall timeline
FDA terminated this recall 19 months after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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.
Official source: FDA Recall #Z-2381-2021 (July 30, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2381-2021 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.