Versea Diagnostics LLC: Medical Device Recall in 2021 - (Recall #: Z-2410-2021)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2021.

Data Source: FDA.

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)

Product Classification:

Class II

Date Initiated: July 27, 2021

Date Posted: September 8, 2021

Recall Number: Z-2410-2021

Event ID: 88429

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.

Status: Terminated

Product Quantity: 563,290 in total

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.

Voluntary or Mandated:

Voluntary: Firm initiated