OPTI Medical Systems, Inc: Medical Device Recall in 2021 - (Recall #: Z-2310-2021)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2021.

Data Source: FDA.

Product Description:

OPTI SARS-CoV-2 RT-PCR Test, REF Numbers: a) 99-57003 b) 99-57004

Product Classification:

Class II

Date Initiated: June 25, 2021

Date Posted: August 25, 2021

Recall Number: Z-2310-2021

Event ID: 88344

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.

Status: Ongoing

Product Quantity: 3552 kits

Code Information:

a) 99-57003, Lot Numbers: 20808, 20812, 20813 b) 99-57004, Lot Numbers: 20881, 20901, 211013

Distribution Pattern:

Maine, New York, Alabama, Pennsylvania, Florida, Illinois, New Jersey, Connecticut, Georgia, Puerto Rico, Costa Rica, Hong Kong, Philippines, Barbados

Voluntary or Mandated:

Voluntary: Firm initiated