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FDA: Roche Test Flaws Could Misdiagnose Patients With COVID-19, Flu

The US agency has contacted health care providers to warn them about faulty COBAS SARS-CoV-2 and Influenza A/B Nucleic Acid Tests for use on the COBAS Liat System.

Roche offices in Warsaw, Poland

The US Food and Drug Administration says Roche Molecular Diagnostics’ COBAS SARS-CoV-2 and Influenza A/B Nucleic Acid Test for use on the COBAS Liat System may be giving patients false positives, leading them to undergo unnecessary treatments and other measures. The tests were a major reason for the company’s profit growth last year.

The agency on 12 March said it had been notified by Roche that the problem with their polymerase chain reaction (PCR) tests may be related to two issues. First, assay...

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