FDA Warning Letter Delivered to Cue Health in May 2024
May 17th, 2024 // 5:08 pm @ jmpickett
Cue Health recently slashed 49% of its staff, but the hits keep on coming for the medical device company. FDA sent Cue Health an FDA warning letter this month regarding the firm’s Emergency Use Authorized COVID-19 test.
In a press release, FDA stated that it warns caregivers, healthcare providers, and home test users to not use the COVID-19 Tests For Home and Over The Counter Use from Cue Health. There is a higher-than-normal risk of false test results.
FDA also stated that it sent a warning letter to Cue Health on May 10, 2024. A recent FDA inspection showed that Cue Health made changes to the tests and these changes altered the reliability of the COVID tests to detect the virus SARS CoV-2.
Cue Health told FDA and the media it is reviewing the warning letter. It expects to release more information this month.
The May warning letter is just the latest headache for Cue Health. The device company stated it would cut 230 staff earlier this year. The firm has been laying people off since 2022, when fewer people used COVID tests.
The COVID-19 testing market is worth $33 billion and will decline about 21% between 2024 to 2030.
