Class 2 Device Recall Cue Health COVID19 Test Cartridge

• Date Initiated by Firm: May 24, 2024
• Date Posted: October 15, 2024
• Recall Status: Open, Classified
• Recall Number: Z-0091-2025
• Recall Event ID: 95392
• Product Classification: Over-the-counter molecular test to detect SARS-CoV-2 from clinical specimens - Product Code QWB
• Product: Cue Health COVID-19 Test Cartridge REF 2900005 Cue COVID-19 Test Cue COVID-19 Test for Home and Over The Counter (OTC)
• 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
• Recalling Firm/ Manufacturer: CUE HEALTH INC; 4980 Carroll Canyon Rd Ste 100; San Diego CA 92121-1736
• For Additional Information Contact: Chanda Owens; 408-518-2578
• Manufacturer Reason for Recall: Due to modified test kits being marketed and distributed without FDA Approval, Clearance or Authorization.
• FDA Determined 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.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.