FDA Medical devices recall ·
Cue Health COVID-19 Test Cartridge recall
- Recall number
- Z-0091-2025
- Date
- (initiated May 24, 2024)
- Company / brand
- Cue Health Inc
4980 Carroll Canyon Rd Ste 100, San Diego, CA, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 56 Lots (248,109 total kits)
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
Cue Health COVID-19 Test Cartridge REF 2900005 Cue COVID-19 Test Cue COVID-19 Test for Home and Over The Counter (OTC)
Why was it recalled?
Due to modified test kits being marketed and distributed without FDA Approval, Clearance or Authorization.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
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
Distribution
U.S. Nationwide distribution.
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-0091-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.