[COVID-19] ​Microbiologics—Helix Elite SARS-CoV-2 Process Control Pellets: May Contain RNA Transcripts That Include Diagnostically Relevant SARS-CoV-2 Targets

September 22, 2021 | Strategic Insights for Health System


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Problem:FDA's Center for Devices and Radiological Health (CDRH) states that the above controls may contain RNA transcripts that include diagnostically relevant SARS-CoV-2 targets (CDC and WHO consensus sequences). FDA's CDRH also states that the manufacturer initiated...

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