Versea FaStep COVID-: Unapproved Lab Use Risk
Versea Diagnostics recalls FaStep COVID-19 IgG/IgM tests for unapproved lab use. Products may be used outside certified labs, risking inaccurate results. No remedy specified.
Recall notice
Products may have been distributed to customers other than laboratories certified under the Clinical Laboratory Improvement Amendments as stipulated in the Emergency Use Authorization.
Contact the company
What happened, in plain English
Versea Diagnostics is recalling its FaStep COVID-19 IgG/IgM Rapid Test Device because it may have been distributed to customers outside of certified laboratories. This could lead to inaccurate test results if used improperly. Read more at govinfonow.com/recall/62142-versea-fastep-covid-unapproved-lab-use-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/62142-versea-fastep-covid-unapproved-lab-use-risk · Updated August 19, 2026 · FDA enforcement record: FDA #Z-2408-2021
Cite this page
“Versea FaStep COVID-: Unapproved Lab Use Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/62142-versea-fastep-covid-unapproved-lab-use-risk. Based on FDA recall #Z-2408-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2408-2021%22&limit=1).
Why it’s dangerous
The tests are designed for use only in labs certified under CLIA regulations. If used outside these certified labs, the results may be inaccurate, potentially leading to incorrect health decisions.
Who’s affected
Anyone who purchased the FaStep test device. People using it outside of CLIA-certified labs are most at risk of inaccurate results.
How to tell if you have this one
The FaStep COVID-19 IgG/IgM Rapid Test Device. All lot codes are affected. The product is intended for use in CLIA-certified laboratories only.
- Brand
Versea Diagnostics- Category
Medical device
All 4 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class II- Status
Terminated- Distribution
US Nationwide Distribution: AL, AZ, CA, CO, CT, FL, GA, IL, KS, OH, OK, MA, MD, MI, NC, NJ, NY, PA, SC, TX, VA, and WA.
| Recall number | Product, codes & lots |
|---|---|
| Z-2407-2021 | CareStart COVID-19 Antigen Rapid Diagnostic Test for the detection of SARS-CoV-2 Antigen Qualitative detection of the nucleocapsid protein antigen from SARS-CoV-2 in nasopharyngeal or anterior nasal swab specimens directly collected from individuals suspected of COVID-19 by their healthcare provider within five days of symptom onset, or from individuals without symptoms or other epidemiological reasons to suspect COVID-19 when tested twice over two or three days with at least 24 hours and no more than 48 hours between tests. (CLIA Waived Laboratories); all lot codes |
| Z-2408-2021 | FaStep COVID-19 IgG/IgM Rapid Test Device Qualitative detection and differentiation of IgM and IgG antibodies to SARS-CoV-2 in human venous whole blood (sodium EDTA), serum, plasma (sodium EDTA) and fingerstick whole blood. Intended for use as an aid in identifying individuals with an adaptive immune response to SARS-CoV-2, indicating recent or prior infection. (CLIA Waived Laboratories); all lot codes |
| Z-2409-2021 | Healgen COVID-19 IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) Qualitative detection and differentiation of IgM and IgG antibodies against SARS-CoV-2 in human venous whole blood, plasma (Li+- heparin, K2-EDTA and sodium-citrate), and serum. Intended for use as an aid in identifying individuals with an adaptive immune response to SARS-CoV-2, indicating recent or prior infection. Emergency use of this test is limited to authorized laboratories. Authorized Laboratories: Laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. 263a, to perform moderate or high complexity tests; all lot codes |
| Z-2410-2021 | Status COVID-19/Flu Rapid Immunoassay for Direct Detection and Differential Diagnosis of SARS-CoV-2, Influenzas Type A, and Type B Antigens Simultaneous qualitative detection and differentiation of nucleocapsid antigen from SARS-CoV-2, influenza A and influenza B directly from nasopharyngeal swab specimens obtained from individuals, who are suspected of respiratory viral infection consistent with COVID-19 by their healthcare provider, within the first five days of onset of symptoms. Emergency use of this test is limited to authorized laboratories. (CLIA Waived Laboratories); all lot codes |
What to do — step by step
Check Lab Certification
Verify if your test was used in a CLIA-certified laboratory. If not, the product may be unsafe.
Where it went and when
Where it was distributed
Distributed nationwide; the notice names 22 states.
FDA distribution: “US Nationwide Distribution: AL, AZ, CA, CO, CT, FL, GA, IL, KS, OH, OK, MA, MD, MI, NC, NJ, NY, PA, SC, TX, VA, and WA.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Alabama, Arizona, California, Colorado, Connecticut, Florida, Georgia, Illinois, Kansas, Maryland, Massachusetts, Michigan, New Jersey, New York, North Carolina, Ohio, Oklahoma, Pennsylvania, South Carolina, Texas, Virginia, Washington.
Recall timeline
FDA terminated this recall 2.7 years after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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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-2408-2021 (July 27, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2408-2021 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.