The Recall Desk
HighFDA (Devices)·Z-2409-2021·Announced 2021-09-08

Healgen COVID-19 Rapid Test Cassette Recalled Due to Unauthorized Laboratory Distribution

Healgen COVID-19 IgG/IgM Rapid Test Cassettes were distributed to laboratories not certified under CLIA, violating Emergency Use Authorization requirements. Unauthorized labs may produce inaccurate test results.

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. This is a risk-of-harm medical device where improper use by non-CLIA-certified laboratories could produce inaccurate diagnostic results, but actual harm has not been reported.

Plain-English summary

Versea Diagnostics LLC is recalling the Healgen COVID-19 IgG/IgM Rapid Test Cassette, which is used to detect IgM and IgG antibodies against SARS-CoV-2 in whole blood, plasma, and serum samples to identify individuals with an adaptive immune response to SARS-CoV-2.

The recall was initiated because the test cassettes were distributed to customers other than laboratories certified under the Clinical Laboratory Improvement Amendments (CLIA) to perform moderate or high complexity testing. Under the test's Emergency Use Authorization, it is authorized for use only in CLIA-certified laboratories. A total of 563,290 units were affected across all lot codes. Nationwide distribution occurred in Alabama, Arizona, California, Colorado, Connecticut, Florida, Georgia, Illinois, Kansas, Ohio, Oklahoma, Massachusetts, Maryland, Michigan, North Carolina, New Jersey, New York, Pennsylvania, South Carolina, Texas, Virginia, and Washington.

Non-certified laboratories may lack the proper training, equipment, and procedures to correctly perform or interpret the test. Use of the test outside of authorized settings could result in inaccurate diagnostic results and potential misdiagnosis.

Laboratories and healthcare providers who received these test cassettes should verify their CLIA certification status and ensure use only in authorized settings. Results obtained from non-certified laboratories should be considered unreliable.

The recalled product

Product
Healgen COVID-19 IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) Qualitative detection and differentiation of IgM and IgG antibodies against SARS-CoV-2 in human venous whole blood, plasma (Li+- heparin, K2-EDTA and sodium-citrate), and serum. Intended for use as an aid in
Manufacturer
Versea Diagnostics LLC
Category
Medical Device — Diagnostic Test
Hazard
  • unauthorized-distribution
  • diagnostic-inaccuracy

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

Same category