Thera Test EL-Anti-SARS-CoV-2 IgG Kit: False Positive Risk

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Contact the company & request your remedy

Recalling firmThera Test Laboratories, Inc.1120 N Du Page Ave, N/A · Lombard, IL 60148-1247

No email on file — write to the address above instead.

✎ GovInfoNow plain-language explainer

What happened, in plain English

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.

Why it’s dangerous

The test kit may show a positive result for COVID-19 when the person does not actually have the virus. This cross-reactivity could lead to false positives, causing unnecessary anxiety or incorrect health decisions.

Who’s affected

People who purchased the EL-Anti-SARS-CoV-2 IgG Kit (Catalog #104-130) with lot numbers 05204351 (expires May 1, 2021) or 05204368 (expires May 19, 2021) are affected. Those using the kit for COVID-19 testing are most at risk.

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.

✎ GovInfoNow

Questions people ask

Why is this kit being recalled?

The kit may show false positive results for COVID-19 due to cross-reactivity, which could lead to unnecessary health concerns.

What should I do if I have this kit?

Check the kit's lot number and catalog number. If it matches the recalled lots (05204351 or 05204368), contact Thera Test for guidance.

Is there a fix for this issue?

The recall record does not mention a remedy or fix for the false positive issue.

Take action

Contact Thera Test

We’ve drafted a message you can send Thera Test to request your refund or repair — edit it as you like.

✉️ Open in email

Subject: Recall Z-2382-2021 — Thera Test Thera Test

Hello,

I own a Thera Test that is covered by recall Z-2382-2021 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.

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Where this comes from

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.

Thera Test Laboratories, Inc. recalls EL-Anti-SARS-CoV-2 IgG Kit, Catalog #104-130. Submitted as EUA202128

Lower-risk recall