CUE HEALTH INC: Medical Device Recall in 2024 - (Recall #: Z-0091-2025)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2024.

Data Source: FDA.

Product Description:

Cue Health COVID-19 Test Cartridge REF 2900005 Cue COVID-19 Test Cue COVID-19 Test for Home and Over The Counter (OTC)

Product Classification:

Class II

Date Initiated: May 24, 2024

Date Posted: October 23, 2024

Recall Number: Z-0091-2025

Event ID: 95392

Reason for Recall:

Due to modified test kits being marketed and distributed without FDA Approval, Clearance or Authorization.

Status: Ongoing

Product Quantity: 56 Lots (248,109 total kits)

Code Information:

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 Pattern:

U.S. Nationwide distribution.

Voluntary or Mandated:

Voluntary: Firm initiated