FDA Warns About Counterfeit COVID-19 Tests
Counterfeit versions of diagnostics from ACON Laboratories and iHealth are being illegally imported to and sold in the US, the agency says. The alert also tells consumers how to spot counterfeit tests.
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The agency says the diagnostics could produce inaccurate results, which may delay proper treatment and further the spread of COVID-19.
The US Government Accountability Office reviewed how the FDA reviewed and monitored COVID-19 tests during the pandemic and found room for improvement. One particular concern was the lack of a straightforward policy on when enforcement discretion would be used.
The tests are being moved to class II, special controls, after the agency determined that would be enough to ensure device safety and efficacy.