Recall Z-2310-2021 ยท QJR Reagents, 2019-Novel Coronavirus Nucleic Acid
OPTI Medical Systems, Inc
OPTI SARS-CoV-2 RT-PCR Test, REF Numbers: a) 99-57003 b) 99-57004
| Date | Jun 25, 2021 |
| Status | Open, Classified |
| 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. |
| Root cause | Nonconforming Material/Component |
| Action | /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. |
| Quantity | 3552 kits |
| Distribution | Maine, New York, Alabama, Pennsylvania, Florida, Illinois, New Jersey, Connecticut, Georgia, Puerto Rico, Costa Rica, Hong Kong, Philippines, Barbados |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.