CLASS II Device recall · Reported 8 Sep 2021 · FDA Enforcement Report
FaStep Covid-19 IgG/IgM Rapid Test Device Qualitative recalled
Versea Diagnostics is recalling FaStep Covid-19 IgG/IgM Rapid Test Device Qualitative detection and differentiation of, distributed nationwide in the US. The recall was initiated on 27 Jul 2021 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2408-2021
- FDA event ID
- 88429
- Recalling firm
- Versea Diagnostics, Tampa, FL
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 27 Jul 2021
- FDA classified
- 2 Sep 2021
- Reported
- 8 Sep 2021
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Other Reasons
- Device type
- Test Kits & Diagnostics
Timeline
| 27 Jul 2021 | Recall initiated by company | |
| 2 Sep 2021 | Classified by FDA | +37 days |
| 8 Sep 2021 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Products may have been distributed to customers other than laboratories certified under the Clinical Laboratory Improvement Amendments as stipulated in the Emergency Use Authorization.
Product as listed by the FDA
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)
Where it was distributed
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.
Nationwide AlabamaArizonaCaliforniaColoradoConnecticutFloridaGeorgiaIllinoisKansasMassachusettsMarylandMichiganNorth CarolinaNew JerseyNew YorkOhioOklahomaPennsylvaniaSouth CarolinaTexas
Questions about this recall
Is FaStep Covid-19 IgG/IgM Rapid Test Device Qualitative detection and differentiation of recalled?
Yes. Versea Diagnostics recalled FaStep Covid-19 IgG/IgM Rapid Test Device Qualitative detection and differentiation of on 27 Jul 2021. The recall is Class II and its status is Terminated. Recall number Z-2408-2021.
Why was it recalled?
Products may have been distributed to customers other than laboratories certified under the Clinical Laboratory Improvement Amendments as stipulated in the Emergency Use Authorization.
Which lots are affected?
all lot codes
Where was it sold?
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.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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