OPTI Medical Systems, Inc Recall 88344
Description: OPTI SARS-CoV-2 RT-PCR Test, REF Numbers: a) 99-57003 b) 99-57004
OPTI Medical Systems, Inc Recall 88344 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-2310-2021 |
| Event ID | 88344 |
| Event Description | OPTI SARS-CoV-2 RT-PCR Test, REF Numbers: a) 99-57003 b) 99-57004 |
| Product Type | Devices |
| Distribution | Maine, New York, Alabama, Pennsylvania, Florida, Illinois, New Jersey, Connecticut, Georgia, Puerto Rico, Costa Rica, Hong Kong, Philippines, Barbados |
| Quantity | 3552 kits |
| Recall 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. |
| Device Classification | 20210825 |
| Device Code Info | a) 99-57003, Lot Numbers: 20808, 20812, 20813 b) 99-57004, Lot Numbers: 20881, 20901, 211013 |
| Center Classification Date | 20210817 |
| Recall Initiation Date | 20210625 |
| Recalling Firm | OPTI Medical Systems, Inc |
| Initial Notification | |
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