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

Recall date

June 25, 2021

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2310-2021

FDA classification

Class II

Brand / firm

OPTI Medical Systems, Inc

Sold / distributed

Maine, New York, Alabama, Pennsylvania, Florida, Illinois, New Jersey, Connecticut, Georgia, Puerto Rico, Costa Rica, Hong Kong, Philippines, Barbados

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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