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Versea Diagnostics LLC recalls CareStart COVID-19 Antigen Rapid Diagnostic Test for the detection of SARS-CoV-2 Antigen Qualitative detection of the n
Recalled September 8, 2021 · FDA recall Z-2407-2021 · Versea Diagnostics
Hazard
Products may have been distributed to customers other than laboratories certified under the Clinical Laboratory Improvement Amendments as stipulated in the Emergency Use Authorization. · FDA Class II
Units
563,290 in total
Sold at
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.
Description
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
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)
Manufacturer(s)
Versea Diagnostics LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →