Reported Oct 23, 2024 · Ongoing
Cue Health COVID-19 Test Cartridge REF 2900005 Cue COVID-19 Test Cue COVID-19 Test for Home and Over The Counter (OTC)
Cue Health Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: CUE HEALTH INC · 4980 Carroll Canyon Rd Ste 100 · San Diego, CA · 92121-1736
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- Cue Health COVID-19 Test Cartridge REF 2900005 Cue COVID-19 Test Cue COVID-19 Test for Home and Over The Counter (OTC)
- Lot codes and dates
- Product code2900005
- UDI codeN/A
- Lot Numbers
30757C30761G30760C30884G30885G30762G30886G30879C30882C30918C30889G30926G30923C31032G30924C31040C31041C31033G31042C31043C31044C31036G31045C31046C31037G31158C31162C31161C31165B31163E31166B31038B31374B31373E31400B31465E31464B31403B31408E31404B31476B31410E31477B31478B31540B31541B31542B31543B31544B31545B31546B31479B31480B31537L31739L
- Amount recalled
- 56 Lots (248,109 total kits)
Where it was sold
- Nationwide
Why it was recalled
Due to modified test kits being marketed and distributed without FDA Approval, Clearance or Authorization.
This product could cause temporary or reversible health problems — stop using it.
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