Z-2310-2021 Class II Ongoing
FDA device recall Z-2310-2021 was initiated by OPTI Medical Systems, Inc on June 25, 2021 and is designated Class II. 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. The recall status is ongoing. Affected quantity: 3552 kits.
Recall Details
- Product Type
- Devices
- Report Date
- August 25, 2021
- Initiation Date
- June 25, 2021
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 3552 kits
Product Description
OPTI SARS-CoV-2 RT-PCR Test, REF Numbers: a) 99-57003 b) 99-57004
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 Pattern
Maine, New York, Alabama, Pennsylvania, Florida, Illinois, New Jersey, Connecticut, Georgia, Puerto Rico, Costa Rica, Hong Kong, Philippines, Barbados
Code Information
a) 99-57003, Lot Numbers: 20808, 20812, 20813 b) 99-57004, Lot Numbers: 20881, 20901, 211013