Lusys Laboratories, Inc.: Medical Device Recall in 2022 - (Recall #: Z-0716-2022)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2022.

Data Source: FDA.

Product Description:

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

Product Classification:

Class I

Date Initiated: January 13, 2022

Date Posted: March 16, 2022

Recall Number: Z-0716-2022

Event ID: 89539

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.

Status: Ongoing

Product Quantity: 14,745 kits

Code Information:

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

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated