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

August 25, 2021 | Strategic Insights for Health System


​ECRI's complete weekly summary of medical device hazard and recall information is available in ECRI's Health Device Alerts. For more information contact us at clientservices@ecri.org.

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...

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