CLASS II ONGOING Device recall · Reported 25 Aug 2021 · FDA Enforcement Report

Opti Sars-CoV-2 Rt-pcr Test recalled by OPTI Medical Systems

OPTI Medical Systems is recalling Opti Sars-CoV-2 Rt-pcr Test, distributed in 10 states. The recall was initiated on 25 Jun 2021 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesa) 99-57003, Lot Numbers: 20808, 20812, 20813 b) 99-57004, Lot Numbers: 20881, 20901, 211013
Quantity recalled3552 kits

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number
Z-2310-2021
FDA event ID
88344
Recalling firm
OPTI Medical Systems, Roswell, GA
Classification
Class II
Status
Ongoing
Recall initiated
25 Jun 2021
FDA classified
17 Aug 2021
Reported
25 Aug 2021
Type
Voluntary: Firm initiated
Customers notified by
E-Mail
Reason category
Other Reasons

Timeline

25 Jun 2021Recall initiated by company
17 Aug 2021Classified by FDA+53 days
25 Aug 2021Published in enforcement report+8 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

Product as listed by the FDA

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

Where it was distributed

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

AlabamaConnecticutFloridaGeorgiaIllinoisMaineNew JerseyNew YorkPennsylvaniaPuerto Rico

Questions about this recall

Is Opti Sars-CoV-2 Rt-pcr Test recalled?

Yes. OPTI Medical Systems recalled Opti Sars-CoV-2 Rt-pcr Test on 25 Jun 2021. The recall is Class II and its status is Ongoing. Recall number Z-2310-2021.

Why was it recalled?

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.

Which lots are affected?

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

Where was it sold?

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

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from OPTI Medical Systems

All 3
ReportedClassRecallCompanyReasonWhere
DeviceCLASS IIModel BP7507 Opti Lion E-Plus Cassettes 25 Cassettes with Sample recalledOPTI Medical SystemsDevice MalfunctionNationwide
DeviceCLASS IIBP7561 Opti Cca-ts B-Lac Cassette recalled by OPTI Medical SystemsOPTI Medical SystemsDevice MalfunctionNationwide

Other Test Kits & Diagnostics recalls

All 2,656
ReportedClassRecallCompanyReasonWhere
DeviceCLASS IISTA Staclot Protein S recalled by Diagnostica StagoDiagnostica StagoPotency & AssayNationwide
DeviceCLASS IIDxC 500i Clinical Analyzer Modules using recalled by Beckman CoulterBeckman CoulterPackaging DefectsNationwide
DeviceCLASS IIDxC 500 AU Clinical Analyzer Modules using recalled by Beckman CoulterBeckman CoulterPackaging DefectsNationwide
DeviceCLASS IISyva EMIT 2000 Quinidine Assay recalledSiemens Healthcare DiagnosticsLead & Heavy MetalsNationwide
DeviceCLASS IIBeckman Coulter, Emit 2000 Quinidine Assay recalledSiemens Healthcare DiagnosticsLead & Heavy MetalsNationwide