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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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
Distribution
Distributed nationwide across the United States.
Related recalls
Same hazard · unapproved device
See all →- ModerateCovidien esophageal stethoscope temperature sensors lack FDA clearance
FDA (Devices) · 2026-06-10
- ModerateCovidien 9 Fr Mon-a-Therm temperature probes lack FDA clearance
FDA (Devices) · 2026-06-10
- ModerateCovidien Mon-a-Therm general purpose temperature probes lack FDA clearance
FDA (Devices) · 2026-06-10
- ModerateOne Step 10A In Vitro Diagnostic Test Distributed Without FDA Clearance
FDA (Devices) · 2026-05-13
- ModerateOne Step K in vitro diagnostic test recall for missing FDA clearance
FDA (Devices) · 2026-05-13
Similar recalls
- SevereFDA Recalls Unauthorized E25Bio COVID-19 Diagnostic Test Kit
FDA (Devices) · 2022-02-16
- SevereCOVID-19 Self-Test Kit Distributed Without Clinical Investigation Authorization
FDA (Devices) · 2021-06-16
- SevereCOVID-19 Rapid Antigen Test Kit Distributed Without FDA Approval
FDA (Devices) · 2022-02-09
- SevereFDA Recalls Innova COVID-19 Self-Test Kits Due to Unauthorized Distribution
FDA (Devices) · 2021-06-16
- HighMatrix COVID-19 Test Kits Recalled for Unauthorized Home Sample Collection
FDA (Devices) · 2022-04-27
- SevereCOVID-19 Rapid Antigen Test Kits Recalled for Unauthorized Distribution
FDA (Devices) · 2022-05-18