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FDA Warns of False Positive Risks for Thermo Fisher’s COVID-19 Test Kit

August 19, 2020

Thermo Fisher Scientific’s TaqPath COVID-19 combo kit could deliver false positive results if samples are not handled correctly, the FDA said in an alert to clinical laboratory staff and healthcare providers.

Based on customer complaints, the company found that inadequate centrifuging of the test’s reverse transcription polymerase chain reaction (RT-PCR) plates could lead to false positives.

Thermo Fisher has updated the test’s instructions and is providing updated software to improve the test’s positive control.

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