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FDAJune 25, 2021device

OPTI SARS-CoV-2 RT-PCR Test, REF Numbers: a) 99-57003 b) 99-57004

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

The firm identified a precipitation issue which may cause late Ct reactors (a false positive result) with a rate of 5 to 10% for affected vials of RNA Master Mix.

What to do

FDA enforcement status: Ongoing

Brands named

opti medical systemsoptiopti medical

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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OPTI SARS-CoV-2 RT-PCR Test, REF Numbers: a) 99-57003 b) 99-57004 — Recall Details · AllClear