Recall archive / FDA device enforcement
Cue Health COVID-19 Test Cartridge REF 2900005 Cue COVID-19 Test Cue COVID-19 Test for Home and Over The Counter (OTC) — FDA record Z-0091-2025
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 May 24, 2024. 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
- Cue Health COVID-19 Test Cartridge REF 2900005 Cue COVID-19 Test Cue COVID-19 Test for Home and Over The Counter (OTC)
- Reason
- Due to modified test kits being marketed and distributed without FDA Approval, Clearance or Authorization.
- Classification
- Class II
- Recalling firm
- CUE HEALTH INC
- Quantity
- 56 Lots (248,109 total kits)
- Agency-reported status
- Ongoing
- Source record identifier
- Z-0091-2025
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 | Product code: 2900005 UDI code: N/A Lot Numbers: 30757C 30761G 30760C 30884G 30885G 30762G 30886G 30879C 30882C 30918C 30889G 30926G 30923C 31032G 30924C 31040C 31041C 31033G 31042C 31043C 31044C 31036G 31045C 31046C 31037G 31158C 31162C 31161C 31165B 31163E 31166B 31038B 31374B 31373E 31400B 31465E 31464B 31403B 31408E 31404B 31476B 31410E 31477B 31478B 31540B 31541B 31542B 31543B 31544B 31545B 31546B 31479B 31480B 31537L 31739L |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
U.S. 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
- Oct 23, 2024
- Recall initiation date
- May 24, 2024
- Center classification date
- Oct 15, 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.