The cross-reactivity of the device may present an increased level of potential false positives. Submitted as EUA202128
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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 its EL-Anti-SARS-CoV-2 IgG Kit (Catalog #104-130) because it may give false positive results for COVID-19. This could lead to unnecessary health concerns or incorrect testing conclusions. Read more at govinfonow.com/recall/64121-thera-test-el-anti-sars-cov-2-igg-kit-false.
“Thera Test EL-Anti-SARS-CoV-2 IgG Kit: False Positive Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/64121-thera-test-el-anti-sars-cov-2-igg-kit-false. Based on FDA recall #Z-2382-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2382-2021%22&limit=1).
Thera Test Laboratories, Inc. recalled the EL-Anti-SARS-CoV-2 IgG Kit, Catalog #104-130, due to potential false positives from cross-reactivity, according to the FDA on October 5, 2020.
How to tell if you have it
Brand: Thera Test
Product: EL-Anti-SARS-CoV-2 IgG Kit
Catalog #: 104-130
Lot numbers: 05204351 (exp. 5/1/2021), 05204368 (exp. 05/19/2021)
Quantity: 19 kits
Distribution: California, Florida, Illinois, Indiana, North Carolina, Texas
The hazard
The cross-reactivity of the device may present an increased level of potential false positives.
Context
GovInfoNow's records show Thera Test Laboratories, Inc. has one other recall on record since July 30, 2020: the EL-Anti-SARS-CoV-2 IgM Kit recalled on that date for not meeting updated EUA packet requirements. Other recent recalls of similar products include the Diagnostica Stago Asserachrom HPIA Kit (December 15, 2025), the Sperm Ab ELISA Test Kit (July 2, 2026), and the Immunotech Estrone RIA Kit (December 15, 2025).
How to tell if you have this one
Check the kit's catalog number (104-130) and lot numbers: 05204351 (expires May 1, 2021) or 05204368 (expires May 19, 2021).
Brand
Thera Test
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Kit Details
Look for catalog number 104-130 and lot numbers 05204351 or 05204368 on the kit 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 California, Florida, Illinois, Indiana, North Carolina, and Texas.” 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 16 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-2382-2021 (October 5, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2382-2021 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.