CLASS II ONGOING Device recall · Reported 23 Oct 2024 · FDA Enforcement Report
Covid-19 Test Cartridge recalled by Cue Health
CUE Health is recalling Covid-19 Test Cartridge, distributed nationwide in the US. The recall was initiated on 24 May 2024 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0091-2025
- FDA event ID
- 95392
- Recalling firm
- CUE Health, San Diego, CA
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 24 May 2024
- FDA classified
- 15 Oct 2024
- Reported
- 23 Oct 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Press Release
- Reason category
- Other Reasons
- Device type
- Test Kits & Diagnostics
Timeline
| 24 May 2024 | Recall initiated by company | |
| 15 Oct 2024 | Classified by FDA | +144 days |
| 23 Oct 2024 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Due to modified test kits being marketed and distributed without FDA Approval, Clearance or Authorization.
Product as listed by the FDA
Cue Health COVID-19 Test Cartridge REF 2900005 Cue COVID-19 Test Cue COVID-19 Test for Home and Over The Counter (OTC)
Where it was distributed
U.S. Nationwide distribution.
Questions about this recall
Why was it recalled?
Due to modified test kits being marketed and distributed without FDA Approval, Clearance or Authorization.
Which lots are affected?
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
Where was it sold?
U.S. Nationwide distribution.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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