FDA Recalls COVID Test Kit: ‘Devices May Cause Serious Injuries or Death’

“The most serious type of recall,” says FDA.

QUICK FACTS:
  • “The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death,” according to the U.S. Food and Drug Administration website.
  • Innova Medical Group is recalling its SARS-CoV-2 Antigen Rapid Qualitative Test.
  • The test kit was recalled because performance claims “did not accurately reflect the performance estimates observed during the clinical studies of the tests.”
  • The test kit also presents risk of showing false positives as well as false negatives. “The performance characteristics of the test have not been adequately established, presenting a risk of false results,” says the FDA.
  • People who were tested using these devices, health care providers, and organizers of large testing programs may have been affected by the defective tests.
  • At least 77,339 kits are being recalled.
INNOVA MEDICAL GROUP SENDS AN “URGENT” RECALL LETTER:
  • On April 23, 2021, Innova Medical Group sent all affected device users an Urgent Medical Device Recall letter, according to the FDA.
  • The letter said, “Do not use these tests to screen for or diagnose COVID-19.
  • It also said to “Identify and remove all affected tests from inventory.”
  • “Either destroy the tests by placing them in the trash or return the tests using the FedEx return label that was included with the letter Innova sent to its customers,” the letter also said.
  • “Complete and return the form Innova sent to its customers, indicating the number of destroyed or returned tests.”
WHY FALSE-NEGATIVE RESULTS ARE DANGEROUS:
  • False-negative results may lead to delayed diagnosis or inappropriate treatment of SARS-CoV-2,” writes the FDA, “which may cause patient harm including serious illness and death.”
  • “False-negative results can also lead to further spread of the SARS-CoV-2 virus, including when presumed negative patients are grouped into cohorts in health care, long-term care, and other facilities based on false test results.”
WHY FALSE-POSITIVE RESULTS ARE DANGEROUS:
  • “False-positive results could lead to a delay in the correct diagnosis and the initiation of an appropriate treatment for the actual cause of patient illness,” also writes the FDA, “which could be another life-threatening disease that is not SARS-CoV-2.”
  • “False-positive results could also lead to further spread of the SARS-CoV-2 virus when presumed positive patients are grouped into cohorts based on false test results.”
DEVICE DESCRIPTION:
  • “The Innova SARS-CoV-2 Antigen Rapid Qualitative Test claimed to determine if a person has an active COVID-19 infection. The test used a nasal swab sample and test strip to detect specific proteins, called antigens, from the SARS-CoV-2 virus,” writes the FDA.
  • “If the nasal sample had SARS-CoV-2 antigens, a colored test line should have appeared on the test strip, indicating that the person may have COVID-19. If the nasal sample did not have SARS-CoV-2 antigens, a colored line should not have appeared on the test strip. The test has not been authorized, cleared, or approved by FDA for commercial distribution in the United States.”
BACKGROUND:
  • Innova SARS-CoV-2 Antigen Rapid Qualitative Test is also distributed under the names Innova COVID-19 Self-Test Kit (3T Configuration), Innova SARS-CoV-2-Antigen Rapid Qualitative Test (7T Configuration), and Innova SARS-CoV-2-Antigen Rapid Qualitative Test (25T Configuration), according to the FDA.
  • The kit was manufactured from September 1, 2020 to March 3, 2021.
  • They were distributed from November 2, 2020 to March 22, 2021.
  • American Faith reported earlier this month that Johnson & Johnson, AstraZeneca, and Oxford University were teaming up with outside scientists to consider “re-engineering” their Covid-19 vaccines in order to lower the risk of serious blood clotting associated with their shots.

Jon Fleetwood is Managing Editor for American Faith.