Z-0091-2025Class II

Cue Health COVID-19 Test Cartridge REF 2900005 Cue COVID-19 Test Cue COVID-19 Test for Home and Over The...

Name: Z-0091-2025 Cue Health COVID-19 Test Cartridge REF 2900005 Cue COVID-19 Test Cue COVID-19 Test for Home and Over The...
Creator: Cue Health Inc
Published: 2024-05-24
License: https://open.fda.gov/license/

Cue Health, Inc. / initiated 2024-05-24 / Open, Classified

FDA source

CUE HEALTH INC began a recall of Cue Health COVID-19 Test Cartridge REF 2900005 Cue COVID-19 Test Cue COVID-19 Test for Home and Over The Counter (OTC) on 2024-05-24. FDA classified it as Class II and gives the reason as "Due to modified test kits being marketed and distributed without FDA Approval, Clearance or Authorization". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-0091-2025
Classification: Class II
Status: Open, Classified
Initiated: 2024-05-24
Posted: 2024-10-15
Recalling firm: Cue Health, Inc.
Product: Cue Health COVID-19 Test Cartridge REF 2900005 Cue COVID-19 Test Cue COVID-19 Test for Home and Over The Counter (OTC)
Product code: QWB Over-The-Counter Molecular Test To Detect Sars-Cov-2 From Clinical Specimens
Reason for recall: Due to modified test kits being marketed and distributed without FDA Approval, Clearance or Authorization.
FDA root cause: No Marketing Application
Action: On 05/13/2024, FDA issued a Field Safety Notice informing/warning the public to not use Cue Health's COVID-19 Tests due to an increased risk of false results. The FDA issued a Warning Letter to Cue Health after an inspection revealed that the company made changes to these tests and that the changes reduced the reliability of the test to detect SARS-CoV-2 virus. Recommendations for Health Care Providers Do not use any Cue Health COVID-19 Tests that you may still have. Dispose of the entire test cartridge in your general waste disposal. Consider retesting your patients using a different FDA authorized test if you suspect an inaccurate result was given Cue COVID-19 Test. If testing was performed more than two weeks ago, and there is no reason to suspect current SARS-CoV-2 infection, it is not necessary to retest. Report any problems you experience with the Cue Health COVID-19 Test to the FDA, including suspected false results. See Reporting Problems with Your Test. FDA Actions The FDA issued Emergency Use Authorizations (EUAs) to Cue Health for two COVID-19 tests, both of which are intended to detect genetic material from SARS-CoV-2 virus in the nostrils. The Cue Health COVID-19 Test received initial EUA authorization on June 10, 2020. It is for use in point-of-care settings. The Cue Health COVID-19 Test for Home and Over-the-Counter Use received initial EUA authorization on March 5, 2021, and is authorized for use at home. The FDA issued a Warning Letter to Cue Health on May 10, 2024, after an inspection revealed the company made changes to these tests and these changes reduced the reliability of the tests to detect SARS-CoV-2 virus. The FDA is warning home test users, caregivers, and health care providers not to use Cue Health s COVID-19 Tests due to this increased risk of false results. The FDA will keep the public informed if significant new information becomes available.
Quantity in commerce: 56 Lots (248,109 total kits)
Distribution: U.S. Nationwide distribution.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0091-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0091-2025	Class II	Ongoing	Voluntary: Firm initiated	2024-10-23	2024-10-15

Product code QWB

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)