The Recall Desk
HighFDA (Devices)·Z-2410-2021·Announced 2021-09-08

COVID-19/Flu Rapid Test Distributed to Non-Certified Laboratories

COVID-19/Flu rapid diagnostic test was distributed to laboratories not certified under federal clinical standards. The 563,290-unit recall affects nationwide distribution; products were authorized only for CLIA-certified laboratories.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: FDA Class II recall with no reported illnesses or injuries. The hazard—improper distribution to non-certified laboratories—is theoretical and relates to potential diagnostic inaccuracy rather than documented harm.

Plain-English summary

Versea Diagnostics LLC recalled its Status COVID-19/Flu Rapid Immunoassay test because products were distributed to customers other than laboratories certified under the Clinical Laboratory Improvement Amendments (CLIA), in violation of its Emergency Use Authorization.

The test detects and differentiates SARS-CoV-2, influenza A, and influenza B antigens from nasopharyngeal swab specimens. It is classified as a CLIA-waived test and is restricted to use only in CLIA-certified laboratories. All lot codes were recalled; 563,290 units were distributed nationwide across 19 states.

The hazard is that non-certified laboratories lack the regulatory oversight, staff qualifications, and quality assurance required to properly perform, validate, and interpret the test. This creates a risk of diagnostic errors and inaccurate results.

Clinical laboratories and other recipients should verify they are CLIA-certified before using this test. Non-certified recipients should contact Versea Diagnostics LLC for instructions. Healthcare providers relying on COVID-19 or flu testing should confirm the certification status of the performing laboratory.

The recalled product

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
Manufacturer
Versea Diagnostics LLC
Category
Medical Device — Rapid Diagnostic Test
Hazard
  • distribution-error
  • unapproved-use

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • all lot codes

Distribution

Distributed nationwide across the United States.

Related recalls

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