CLASS I ONGOING Device recall · Reported 16 Mar 2022 · FDA Enforcement Report

Luscient Diagnostics 2nd Generation of Covid-19 Viral recalled

Lusys Laboratories is recalling Luscient Diagnostics 2nd Generation of Covid-19 Viral Antigen Test For all mutant variety, distributed nationwide in the US. The recall was initiated on 13 Jan 2022 and the FDA has classified it as Class I.

Check your package

Lot, batch or date codesPart Number: I-114(N) Lot Numbers: All Lots due to not having an authorized Emergency Use Authorization (EUA)

Quantity recalled90,849 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-0717-2022
FDA event ID: 89539
Recalling firm: Lusys Laboratories, San Diego, CA
Classification: Class I
Status: Ongoing
Recall initiated: 13 Jan 2022
FDA classified: 10 Mar 2022
Reported: 16 Mar 2022
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Test Kits & Diagnostics

Timeline

13 Jan 2022	Recall initiated by company
10 Mar 2022	Classified by FDA	+56 days
16 Mar 2022	Published in enforcement report	+6 days

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

Reason for recall

COVID-19 test kits (Antibody Rapid Test kit and Antigen Rapid Test Kit) are not authorized, cleared, or approved for marketing and/or distribution in the U.S.

Product as listed by the FDA

Luscient Diagnostics 2nd Generation of COVID-19 Viral Antigen Test For all mutant variety Cat: I-114(Nasal Swab Test)

Where it was distributed

Worldwide - US Nationwide distribution in the states of CA, NC, NV, OH, TN and TX. The countries of Canada, China, and Mexico. Pending additional information for a complete Consignee Listing

Nationwide California North Carolina Nevada Ohio Tennessee Texas

Questions about this recall

Is Luscient Diagnostics 2nd Generation of Covid-19 Viral Antigen Test For all mutant variety recalled?

Yes. Lusys Laboratories recalled Luscient Diagnostics 2nd Generation of Covid-19 Viral Antigen Test For all mutant variety on 13 Jan 2022. The recall is Class I and its status is Ongoing. Recall number Z-0717-2022.

Why was it recalled?

COVID-19 test kits (Antibody Rapid Test kit and Antigen Rapid Test Kit) are not authorized, cleared, or approved for marketing and/or distribution in the U.S.

Which lots are affected?

Part Number: I-114(N) Lot Numbers: All Lots due to not having an authorized Emergency Use Authorization (EUA)

Where was it sold?

Worldwide - US Nationwide distribution in the states of CA, NC, NV, OH, TN and TX. The countries of Canada, China, and Mexico. Pending additional information for a complete Consignee Listing

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 I mean?

Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.

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 Lusys Laboratories

All 11

Reported	Class	Recall	Company	Reason	Where
16 Mar 2022Device	CLASS I	Covid-19 IgG/Igm Antibody Test For Detection of Covid recalled	Lusys Laboratories	Other	Nationwide
16 Mar 2022Device	CLASS I	LuSys 2nd Generation of Covid-19 Viral Antigen Test For all recalled	Lusys Laboratories	Other	Nationwide
15 Apr 2015Device	CLASS I	Ebola GP IgM Blood (Blood Serum/Plasma/Cassette) recalled	Lusys Laboratories	Other	Nationwide
15 Apr 2015Device	CLASS I	Ebola Accessories assembled, self-contained package recalled	Lusys Laboratories	Packaging Defects	Nationwide
15 Apr 2015Device	CLASS I	Ebola IgX VP-40 Serum/Plasma/Blood Cassette recalled	Lusys Laboratories	Other	Nationwide

Other Test Kits & Diagnostics recalls

All 2,656

Reported	Class	Recall	Company	Reason	Where
9 Sep 2026Device	CLASS II	STA Staclot Protein S recalled by Diagnostica Stago	Diagnostica Stago	Potency & Assay	Nationwide
26 Aug 2026Device	CLASS II	DxC 500i Clinical Analyzer Modules using recalled by Beckman Coulter	Beckman Coulter	Packaging Defects	Nationwide
26 Aug 2026Device	CLASS II	DxC 500 AU Clinical Analyzer Modules using recalled by Beckman Coulter	Beckman Coulter	Packaging Defects	Nationwide
26 Aug 2026Device	CLASS II	Syva EMIT 2000 Quinidine Assay recalled	Siemens Healthcare Diagnostics	Lead & Heavy Metals	Nationwide
26 Aug 2026Device	CLASS II	Beckman Coulter, Emit 2000 Quinidine Assay recalled	Siemens Healthcare Diagnostics	Lead & Heavy Metals	Nationwide