Home / Recalls / OPTI Medical Systems, Inc / Z-2310-2021

Z-2310-2021 Class II Ongoing

Recalled by OPTI Medical Systems, Inc — Roswell, GA

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