Thera Test Laboratories, Inc. recalls
Every recall we track for Thera Test Laboratories, Inc. — 2 in all, all from 2020 — plus the complaints and injury reports the public filed about them.
Recalls per year, by danger level
2 recalls since 2017.
All FDA recall records for Thera Test Laboratories, Inc. since 2017, counted by recall date (one bar per calendar year; 2026 is partial). Danger level is GovInfoNow’s plain-language rating; “not yet rated” records are still being written up.
| Year | Stop using now | Use caution | Lower risk | Not yet rated | Total |
|---|---|---|---|---|---|
| 2017 | 0 | 0 | 0 | 0 | 0 |
| 2018 | 0 | 0 | 0 | 0 | 0 |
| 2019 | 0 | 0 | 0 | 0 | 0 |
| 2020 | 0 | 0 | 2 | 0 | 2 |
| 2021 | 0 | 0 | 0 | 0 | 0 |
| 2022 | 0 | 0 | 0 | 0 | 0 |
| 2023 | 0 | 0 | 0 | 0 | 0 |
| 2024 | 0 | 0 | 0 | 0 | 0 |
| 2025 | 0 | 0 | 0 | 0 | 0 |
| 2026 (to date) | 0 | 0 | 0 | 0 | 0 |
What to do if you have a recalled Thera Test Laboratories, Inc. product
- Match the model, catalog or lot number on your device to the recall.
- Ask the prescribing clinician or supplier what to do — many device recalls are corrections, not removals.
- Report problems to FDA MedWatch.
All Thera Test Laboratories, Inc. recalls
2 shown- Lower riskMedical device
Thera Test Laboratories, Inc. recalls EL-Anti-SARS-CoV-2 IgG Kit, Catalog #104-130. Submitted as EUA202128
Thera Test recalls EL-Anti-SARS-CoV-2 IgG Kit (Catalog #104-130) due to potential false positives. Affected lots expire May 2021.
Thera TestOct 5, 2020 - Lower riskMedical device
Thera Test Laboratories, Inc. recalls EL-Anti-SARS-CoV-2 IgM Kit, Catalog #104-129, IVD. Submitted as EUA202129
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.
Thera TestJul 30, 2020
Thera Test Laboratories, Inc. recall questions
How many recalls has Thera Test Laboratories, Inc. had?
2 recalls from Thera Test Laboratories, Inc. are on record with U.S. safety agencies, from 2020.
What is the most recent Thera Test Laboratories, Inc. recall?
Thera Test Laboratories, Inc. recalls EL-Anti-SARS-CoV-2 IgG Kit, Catalog #104-130. Submitted as EUA202128, dated Oct 5, 2020. Every Thera Test Laboratories, Inc. recall is listed on this page, newest first.
What should I do if I have a recalled Thera Test Laboratories, Inc. product?
Match the model, catalog or lot number on your device to the recall. Ask the prescribing clinician or supplier what to do — many device recalls are corrections, not removals. Report problems to FDA MedWatch.
How do I get alerts for new Thera Test Laboratories, Inc. recalls?
Sign up for free email alerts on GovInfoNow — we check official CPSC, FDA, USDA and NHTSA data every day and email you only when a recall matches what you follow.