COVID-19 Business Intelligence and Analysis for Clinical Laboratories, Pathology Groups and Hospital Administration

COVID-19 Briefings

Reliable COVID-19 Business Intelligence and analysis for clinical laboratories, pathology groups and Laboratory Diagnostics.

FDA Issues Second Class 1 Recall in Two Weeks for Unauthorized COVID-19 Test

FDA maze of regulations

Second recall and warning by FDA indicate a strong crackdown on unauthorized COVID-19 tests

The US Food and Drug Administration (FDA) issued its second Class 1 recall (the most serious recall the FDA uses) of a COVID-19 test. This one comes less than two weeks after the FDA recalled another COVID-19 test for similar issues.

The first recall occurred May 28, 2021, and it applied to COVID-19 tests sold by Lepu Technology without authorization (See FDA Issues Public Safety Communication Warning Public and Healthcare Providers About COVID-19 Tests Sold By Lepu Technology).

On June 10, 2021, the FDA issued the second and most recent Class 1 recall for COVID-19 testing. Simultaneously, the FDA provided a letter to the public and to healthcare providers, warning them to immediately stop using the affected tests. The test affected by the second recall is the Innova SARS-CoV-2 Antigen Rapid Qualitative Test.

The FDA cited multiple reasons for issuing the warning and recall, including the fact that the test’s performance was not adequately established; the fact that the test had not yet received authorization; and concerns that the data provided by the Innova Medical Group with their emergency use authorization (EUA) application appeared to be copied from data provided by other test manufacturers.

The FDA warns that the Innova SARS-CoV-2 Antigen Rapid Qualitative Test is sold under many names, including:

  • Innova COVID-19 Self-Test Kit (3T Configuration)
  • Innova SARS-CoV-2-Antigen Rapid Qualitative Test (7T Configuration)
  • Innova SARS-CoV-2-Antigen Rapid Qualitative Test (25T Configuration)

The FDA recommends that healthcare providers who have used the Innova SARS-CoV-2 Antigen Rapid Qualitative Test retest any patients who may have experienced an inaccurate result.

Related Resources:

FDA: Stop Using Innova SARS-CoV-2 Antigen Rapid Qualitative Test: FDA Safety Communication

FDA: Stop Using Lepu Medical Technology SARS-CoV-2 Antigen and Leccurate Antibody Tests: FDA Safety Communication

STAT: FDA accuses company of distributing unapproved Covid test and using falsified data