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

Is this the product you have?

  • 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
    • 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
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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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 6:54 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.