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OPTI Medical Systems, Inc recalls OPTI SARS-CoV-2 RT-PCR Test, REF Numbers: a) 99-57003 b) 99-57004
Recalled August 25, 2021 · FDA recall Z-2310-2021 · OPTI Medical Systems
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. · FDA Class II
Units
3552 kits
Sold at
Maine, New York, Alabama, Pennsylvania, Florida, Illinois, New Jersey, Connecticut, Georgia, Puerto Rico, Costa Rica, Hong Kong, Philippines, Barbados
Description
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.
Product
OPTI SARS-CoV-2 RT-PCR Test, REF Numbers: a) 99-57003 b) 99-57004
Manufacturer(s)
OPTI Medical Systems, Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →