Device product
Status COVID-19/Flu Rapid Immunoassay for Direct Detection and Differential Diagnosis of SARS-CoV-2, Influenzas Type A, and Type B Antigens Simultaneous qualitative detection and differentiation of nucleocapsid antigen from SARS-CoV-2, influenza A and influenza B directly from nasopharyngeal swab specimens obtained from individuals, who are suspected of respiratory viral infection consistent with COVID-19 by their healthcare provider, within the first five days of onset of symptoms. Emergency use of this test is limited to authorized laboratories. (CLIA Waived Laboratories)
Z-2410-2021
Product summary
- Event
- Event 88429
- Status
- Terminated
- Classification
- Class II
- Quantity
- 563,290 in total
- Official record key
device-enforcement:Z-2410-2021
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
Products may have been distributed to customers other than laboratories certified under the Clinical Laboratory Improvement Amendments as stipulated in the Emergency Use Authorization.