OPTI SARS-CoV-2 RT-PCR Test, REF Numbers: a) 99-57003 b) 99-57004
This recall is currently active, issued June 25, 2021. It was issued by Opti Medical Systems Inc.
- Company
- Opti Medical Systems Inc
- Recall Initiated
- June 25, 2021
- Recall Number
- Z-2310-2021
- Quantity
- 3552 kits
- Firm Location
- Roswell, GA
- Official Source
- View on FDA website ↗
Reason for Recall
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.
Distribution
Maine, New York, Alabama, Pennsylvania, Florida, Illinois, New Jersey, Connecticut, Georgia, Puerto Rico, Costa Rica, Hong Kong, Philippines, Barbados
Lot / Code Info
a) 99-57003, Lot Numbers: 20808, 20812, 20813 b) 99-57004, Lot Numbers: 20881, 20901, 211013
Root Cause
Nonconforming Material/Component
Action Taken
/The firm disseminated a technical bulletin beginning on 06/25/2021 by email identifying the /problem and providing additional instructions to be implemented when using the product.