Empowered Diagnostics is recalling two Covid-19 tests, CovClear COVID-19 Rapid Antigen Test and ImmunoPass COVID-19 Neutralizing Antibody Rapid Test, as they have been distributed with labels incorrectly indicating that they are US Food and Drug Administration (FDA) authorised.
The FDA has identified the recall of the two products as Class 1, the most serious recall type, as they could potentially lead to a higher risk of false results.
It noted that false results could lead to serious adverse health consequences or death.
A delayed diagnosis of the SARS-CoV-2 virus, leading to further spread of the virus, could be expected due to a false-negative test result.
The CovClear COVID-19 Rapid Antigen Test is designed to detect SARS-CoV-2 antigens from a nasal swab sample.
Meanwhile, the ImmunoPass COVID-19 Neutralizing Antibody Rapid Test uses a fingerstick blood sample to detect antibodies produced by the immune system in response to the SARS-CoV-2 virus.
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Empowered Diagnostics sent a Voluntary Recall e-mail to its distributors and customers, instructing them to stop using and distributing all the affected tests, on 20 December last year.
The FDA is suggesting that test users and caregivers talk to their healthcare provider if they have concerns about their test results after testing with either of the Empowered Diagnostics Covid-19 tests.
Healthcare providers and testing programme organisers are required to consider retesting patients using a SARS-CoV-2 diagnostic test authorised by the FDA if they suspect an inaccurate result following the use of a CovClear COVID-19 Rapid Antigen Test.
However, if testing was performed with CovClear more than two weeks ago and there is no reason to suspect a current infection, no retesting is needed.