FDA-Device2021-08-25Class II
OPTI SARS-CoV-2 RT-PCR Test, REF Numbers: a) 99-57003 b) 99-57004
OPTI Medical Systems, Inc
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.
Sold states
Maine, New York, Alabama, Pennsylvania, Florida, Illinois, New Jersey, Connecticut, Georgia, Puerto Rico, Costa Rica, Hong Kong, Philippines, Barbados
Affected count
3552 kits
Manufactured in
235 Hembree Park Dr, N/A, Roswell, GA, United States
Products
OPTI SARS-CoV-2 RT-PCR Test, REF Numbers: a) 99-57003 b) 99-57004
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2310-2021Don't want to check this manually?
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