Z-2310-2021Class II

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

Name: Z-2310-2021 OPTI SARS-CoV-2 RT-PCR Test, REF Numbers: a) 99-57003 b) 99-57004
Creator: OPTI Medical Systems, Inc
Published: 2021-06-25
License: https://open.fda.gov/license/

Opti Medical Systems Inc / initiated 2021-06-25 / Open, Classified / root cause: manufacturing process

FDA source

OPTI Medical Systems, Inc began a recall of OPTI SARS-CoV-2 RT-PCR Test, REF Numbers: a) 99-57003 b) 99-57004 on 2021-06-25. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2310-2021
Classification: Class II
Status: Open, Classified
Initiated: 2021-06-25
Posted: 2021-08-17
Recalling firm: Opti Medical Systems Inc
Product: OPTI SARS-CoV-2 RT-PCR Test, REF Numbers: a) 99-57003 b) 99-57004
Product code: QJR Reagents, 2019-Novel Coronavirus Nucleic Acid
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.
Root cause tag: manufacturing process
FDA 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 in commerce: 3552 kits
Distribution: Maine, New York, Alabama, Pennsylvania, Florida, Illinois, New Jersey, Connecticut, Georgia, Puerto Rico, Costa Rica, Hong Kong, Philippines, Barbados
Product codes and lots: a) 99-57003, Lot Numbers: 20808, 20812, 20813 b) 99-57004, Lot Numbers: 20881, 20901, 211013

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2310-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2310-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-08-25	2021-08-17

Product code QJR

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)