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Recall Observatory FDA recall evidence

Device product

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)

Z-2408-2021

July 27, 2021

Class II

Product summary

Firm
Versea Diagnostics LLC
Event
Event 88429
Status
Terminated
Classification
Class II
Quantity
563,290 in total
Official record key
device-enforcement:Z-2408-2021

Official wording

Reason: Products may have been distributed to customers other than laboratories certified under the Clinical Laboratory Improvement Amendments as stipulated in the Emergency Use Authorization.

Code information: all lot codes

Distribution pattern: 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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Products may have been distributed to customers other than laboratories certified under the Clinical Laboratory Improvement Amendments as stipulated in the Emergency Use Authorization.