medical Class II Updated 2021-09-08

Versea Diagnostics LLC recalls CareStart COVID-19 Antigen Rapid Diagnostic Test for the det

Recalled 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)


Hazard / Issue

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

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: all lot codes
View official government recall

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