Cue Health COVID-19 Test Cartridge Recalled for Unapproved Distribution
Cue Health Inc. is recalling 248,109 COVID-19 test kits (56 lots) that were modified and distributed without FDA approval or authorization. Users should discontinue use and contact the manufacturer.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This recall involves unapproved diagnostic medical devices presenting a risk-of-harm through unvalidated test performance, with no reported illnesses or injuries. The FDA Class II designation and lack of regulatory approval support a High severity classification.
Plain-English summary
Cue Health Inc. is recalling 248,109 COVID-19 test cartridges (product code 2900005) distributed in 56 specific lots nationwide. These test kits were modified and marketed without FDA approval, clearance, or authorization.
Diagnostic devices distributed without FDA approval have not undergone the agency's validation for safety and effectiveness. No illnesses or injuries have been reported in connection with these devices.
Affected lot numbers are: 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.
Consumers who possess these test kits should not use them and should contact Cue Health Inc. for further instructions.
The recalled product
- Product
- Cue Health COVID-19 Test Cartridge REF 2900005 Cue COVID-19 Test Cue COVID-19 Test for Home and Over The Counter (OTC)
- Manufacturer
- CUE HEALTH INC
- Category
- Medical Device — Diagnostic Test
- Hazard
- unapproved-device
Distribution
Distributed nationwide across the United States.
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