Recall Z-0091-2025 ยท QWB Over-The-Counter Molecular Test To Detect Sars-Cov-2 From Clinical Specimens
CUE HEALTH INC
Cue Health COVID-19 Test Cartridge REF 2900005 Cue COVID-19 Test Cue COVID-19 Test for Home and Over The Counter (OTC)
| Date | Oct 15, 2024 (initiated May 24, 2024) |
| Status | Open, Classified |
| Reason | Due to modified test kits being marketed and distributed without FDA Approval, Clearance or Authorization. |
| 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 |
| Quantity | 56 Lots (248,109 total kits) |
| Distribution | U.S. Nationwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.