[COVID-19] OPTI Medical Systems—SARS-CoV-2 RT-PCR Tests: May Yield False-Positive Results​

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Problem: ​FDA's Center for Devices and Radiological Health (CDRH) states that the above tests may exhibit a precipitation problem, which may cause late Ct reactors (a false-positive result) with a rate of 5% to 10% for affected vials of RNA Master Mix. FDA's CDRH also states that the manufacturer initiated a recall by technical bulletin on June 25, 2021. The manufacturer has not confirmed the...