Recall archive / FDA device enforcement
LumiraDx SARS-CoV-2 Antigen (Ag) Liquid Quality Control Kit Catalog #: L016080109002 (EUA) The LumiraDx SARS-CoV-2 Qu... — FDA record Z-0135-2023
Reported terminated
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 Sep 23, 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
- LumiraDx SARS-CoV-2 Antigen (Ag) Liquid Quality Control Kit Catalog #: L016080109002 (EUA) The LumiraDx SARS-CoV-2 Quality Controls are intended for liquid quality control testing performed on the LumiraDx Instrument when used with the LumiraDx SARS-CoV-2 Ag Test Strip. The Quality Controls provide users with assurance that the device is performing within specification
- Reason
- Assigned vial lot numbers for the incorrect type of product. SARS-CoV-2 & Flu A/B lot numbers were incorrectly assigned to the positive and negative vial lot numbers for SARS-CoV-2 Ag LQCs within batch 2002204017, which should have been assigned SARS-CoV-2 Ag lot numbers resulting in an error message and preventing use of the LQC
- Classification
- Class III
- Recalling firm
- LumiraDx
- Quantity
- 83 kits
- Agency-reported status
- Terminated
- Source record identifier
- Z-0135-2023
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 | LQC Kit: 2002204017 Positive Control Vial: 1000 1710 0014 0141 Negative Control Vial: 1000 1720 0014 0142 Exp. Date: 01-Mar-2023 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
US Nationwide distribution.
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
- Nov 2, 2022
- Recall initiation date
- Sep 23, 2022
- Center classification date
- Oct 26, 2022
- Termination date
- Dec 13, 2024
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.