The Food & Drug Administration
issued a class I recall for a defective COVID rapid test that had been the “benchmark” for testing in the United States. It continues an alarming trend of problems with COVID tests in the United States.
“The FDA has classified the recall of this test as a
Class I recall, the most serious type of recall,” the government agency said. “The FDA also has issued a
warning letter to Innova Medical Group, Inc.”
Innova describes itself as “the world’s largest manufacturer of rapid antigen tests and leader in COVID-19 testing solutions globally.” The FDA states the reasons for the COVID test recall:
“Innova Medical Group is recalling its SARS-CoV-2 Antigen Rapid Qualitative Test. Labeling distributed with certain configurations of the test includes performance claims that did not accurately reflect the performance estimates observed during the clinical studies of the tests. The performance characteristics of the test have not been adequately established, presenting a risk of false results.”
- False-negative results may lead to delayed diagnosis or inappropriate treatment of SARS-CoV-2, 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.
- 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, 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.
“On April 23, 2021, Innova Medical Group sent all affected device users an Urgent Medical Device Recall letter,” the FDA said. “The letter provided the following information”:
- Do not use these tests to screen for or diagnose COVID-19.
- 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.
- Complete and return the form Innova sent to its customers, indicating the number of destroyed or returned tests.
The CDC in June issued an
alert for testing laboratories to stop using the Innova SARS-CoV-2 Antigen Rapid Qualitative Test.
“Innova Medical Group is recalling its SARS-CoV-2 Antigen Rapid Qualitative Test. Labeling distributed with certain configurations of the test includes performance claims that did not accurately reflect the performance estimates observed during the clinical studies of the tests,” the CDC stated. “The performance characteristics of the test have not been adequately established, presenting a risk of false results.”
A number of COVID testing experts reacted to the recall of the Innova rapid tests.
“The Food and Drug Administration issued its STOP notice on Innova’s lateral flow antigen tests in USA on 10th June, by coincidence one day after a Royal Statistical Society (RSS) Working Group had issued its report on diagnostic tests which made 22 recommendations – 10 on study-design, six for regulators and six on transparency,” Professor Sheila Bird of the University of Cambridge remarked.
“The FDA explain that they have withdrawn the Innova test for four main reasons: (a) distribution of the test in the US without approval; (b) erroneous claims on product leaflets; (c) concerns about the reliability of the evidence; and (d) failure to implement appropriate quality assurance processes to ensure that only inspected and approved devices are distributed,” Professor Jon Deeks of the University of Birmingham remarked. “The FDA state that the decision is informed by inspection visits to the distribution sites in the US. Innova have responded stating that they have already or are fixing the issues which concerned the FDA and will reapply for approval.”
It is not the only concerning news on the COVID testing front. Last week, the CDC urged laboratories to switch over to a “multiplexed method” that “can facilitate detection and differentiation of SARS-CoV-2 and influenza viruses.”
reason.com
