Z-2410-2021 Class II Terminated
FDA device recall Z-2410-2021 was initiated by Versea Diagnostics LLC on July 27, 2021 and is designated Class II. 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. The recall status is terminated (terminated April 10, 2024). Affected quantity: 563,290 in total.
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
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)
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