Innova30 Jun 2021 16:07
From the FDA web site
:
Ref Innova SARS-CoV-2 Antigen Rapid Qualitative Test.
Manufacturing Dates: September 1, 2020 to March 3, 2021
Distribution Dates: November 2, 2020 to March 22, 2021
Devices Recalled in the U.S.: At least 77,339
Date Initiated by Firm: March 24, 2021
Reason for 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.