Home / Recalls / Versea Diagnostics LLC / Z-2408-2021

Z-2408-2021 Class II Terminated

Recalled by Versea Diagnostics LLC — Tampa, FL

Recall Details

Product Type: Devices
Report Date: September 8, 2021
Initiation Date: July 27, 2021
Termination Date: April 10, 2024
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 563,290 in total

Product 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)

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.

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.

Code Information

all lot codes