Z-0716-2022Class I

LuSys 2nd Generation of COVID-19 Viral Antigen Test For all mutant variety Cat: I-114(Saliva Test)

Name: Z-0716-2022 LuSys 2nd Generation of COVID-19 Viral Antigen Test For all mutant variety Cat: I-114(Saliva Test)
Creator: Lusys Laboratories, Inc.
Published: 2022-01-13
License: https://open.fda.gov/license/

Lusys Laboratories, Inc. / initiated 2022-01-13 / Open, Classified

FDA source

Lusys Laboratories, Inc. began a recall of LuSys 2nd Generation of COVID-19 Viral Antigen Test For all mutant variety Cat: I-114(Saliva Test) on 2022-01-13. FDA classified it as Class I and gives the reason as "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". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-0716-2022
Classification: Class I
Status: Open, Classified
Initiated: 2022-01-13
Posted: 2022-03-10
Recalling firm: Lusys Laboratories, Inc.
Product: LuSys 2nd Generation of COVID-19 Viral Antigen Test For all mutant variety Cat: I-114(Saliva Test)
Product code: QKP Coronavirus Antigen Detection Test System.
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.
FDA root cause: No Marketing Application
Action: On 01/13 and 24/2022, the firm sent an "URGENT MEDICAL DEVICE RECALL" Letter via certified US Mail to customer informing them that the COVID-19 Antigen Tests (Nasal/Saliva) and COVID-19 IgG/IgM Antibody Tests are being recalled because these tests have not received FDA Emergency Use Authorization, nor have these test been cleared or approved by FDA for commercial distribution. Therefore, these tests cannot be legally marketed or distributed in the U.S., nor can they be legally exported from the U.S.. Because the abovementioned products were not authorized, cleared, or approved by FDA, the performance characteristics of these tests have not been adequately established, might presenting a high risk of false positive and false negative results. Customers are instructed to: 1. Immediately discontinue to use these tests. 2. If your firm has distributed these products, immediately provide all consignees with a copy of this recall notification. 3. Discard or destroy all COVID-19 tests manufactured or distributed by LuSys Laboratories, Inc., a.k.a. Luscient Diagnostics LLC, or return the tests to the following address: 7220 Trade Street, Suite 338, San Diego, CA, 92121, before January 30, 2022. For further questions regarding this Recall: -Call Telephone Number - 858-733-2128, or -email [email protected]
Quantity in commerce: 14,745 kits
Distribution: 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
Product codes and lots: Part Number: I-114(S) Lot Numbers: All Lots due to not having an authorized Emergency Use Authorization (EUA)

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0716-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0716-2022	Class I	Ongoing	Voluntary: Firm initiated	2022-03-16	2022-03-10
Z-0717-2022	Class I	Ongoing	Voluntary: Firm initiated	2022-03-16	2022-03-10
Z-0718-2022	Class I	Ongoing	Voluntary: Firm initiated	2022-03-16	2022-03-10

Product code QKP

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)