Z-0091-2025 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- October 23, 2024
- Initiation Date
- May 24, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 56 Lots (248,109 total kits)
Product Description
Cue Health COVID-19 Test Cartridge REF 2900005 Cue COVID-19 Test Cue COVID-19 Test for Home and Over The Counter (OTC)
Reason for Recall
Due to modified test kits being marketed and distributed without FDA Approval, Clearance or Authorization.
Distribution Pattern
U.S. Nationwide distribution.
Code Information
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