Device product
OPTI SARS-CoV-2 RT-PCR Test, REF Numbers: a) 99-57003 b) 99-57004
Z-2310-2021
Product summary
- Event
- Event 88344
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 3552 kits
- Official record key
device-enforcement:Z-2310-2021
Official wording
Reason: 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.
Code information: a) 99-57003, Lot Numbers: 20808, 20812, 20813 b) 99-57004, Lot Numbers: 20881, 20901, 211013
Distribution pattern: Maine, New York, Alabama, Pennsylvania, Florida, Illinois, New Jersey, Connecticut, Georgia, Puerto Rico, Costa Rica, Hong Kong, Philippines, Barbados
Derived failure modes
-
Unknown
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.