Recall archive / FDA device enforcement
COVID-19 IgG/IGM Antibody Test For Detection of COVID-19 IgG and IgM antibodies Catalog No: I-111 — FDA record Z-0718-2022
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Jan 13, 2022. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- COVID-19 IgG/IGM Antibody Test For Detection of COVID-19 IgG and IgM antibodies Catalog No: I-111
- Reason
- 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.
- Classification
- Class I
- Recalling firm
- Lusys Laboratories, Inc.
- Quantity
- 33,955 kits
- Agency-reported status
- Ongoing
- Source record identifier
- Z-0718-2022
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | Part Number: I-111 Lot Numbers: All Lots due to not having an authorized Emergency Use Authorization (EUA) |
Match all identifying details in the current notice. A brand name alone is not enough.
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
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
- Alaska
- Alabama
- Arkansas
- Arizona
- California
- Colorado
- Connecticut
- Delaware
- Florida
- Georgia
- Hawaii
- Iowa
- Idaho
- Illinois
- Indiana
- Kansas
- Kentucky
- Louisiana
- Massachusetts
- Maryland
- Maine
- Michigan
- Minnesota
- Missouri
- Mississippi
- Montana
- North Carolina
- North Dakota
- Nebraska
- New Hampshire
- New Jersey
- New Mexico
- Nevada
- New York
- Ohio
- Oklahoma
- Oregon
- Pennsylvania
- Rhode Island
- South Carolina
- South Dakota
- Tennessee
- Texas
- Utah
- Virginia
- Vermont
- Washington
- Wisconsin
- West Virginia
- Wyoming
Dates in the source
- Report date
- Mar 16, 2022
- Recall initiation date
- Jan 13, 2022
- Center classification date
- Mar 10, 2022
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.