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Versea Diagnostics LLC Recall 88429

Description: 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)

Versea Diagnostics LLC Recall 88429 Information

StatusCompleted
Mandated?Voluntary: Firm initiated
Recall NumberZ-2408-2021
Event ID88429
Event DescriptionFaStep 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)
Product TypeDevices
DistributionUS 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.
Quantity563,290 in total
Recall ReasonProducts may have been distributed to customers other than laboratories certified under the Clinical Laboratory Improvement Amendments as stipulated in the Emergency Use Authorization.
Device Classification20210908
Device Code Infoall lot codes
Center Classification Date20210902
Recall Initiation Date20210727
Recalling FirmVersea Diagnostics LLC
Initial Notification E-Mail
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