The Cue Reader for the company’s COVID-19 test. [Image courtesy of Cue Health]The FDA today issued a notice classifying the recall of Cue Health COVID-19 tests as Class II and revoking the tests’ EUA.

该公司新型冠状病毒检测的提示读取器。[图片由Cue Health提供]FDA今天发布通知，将Cue Health COVID-19测试的召回归类为II类，并撤销测试的EUA。

Earlier this year, the FDA said an inspection found that the company made changes to tests that previously garnered emergency use authorization (EUA) in 2020 and 2021. Cue Health also won FDA de novo clearance for its at-home and point-of-care molecular COVID-19 test last year. The FDA said these changes reduced the reliability of the tests to detect SARS-CoV-2, the virus causing COVID-19..

今年早些时候，FDA表示，一项检查发现，该公司对之前在2020年和2021年获得紧急使用授权（EUA）的测试进行了更改。Cue Health去年还因其在家和即时分子COVID-19检测获得了FDA的从头批准。FDA表示，这些变化降低了检测SARS-CoV-2（一种引起COVID-19的病毒）测试的可靠性。。

Because this led to the risk of false results, the FDA issued a warning for Cue’s COVID-19 tests in May. That included its home and over-the-counter (OTC) use as well as a test intended for patient care settings. Not long after the warning, the company laid off all remaining U.S. employees (around 230).

由于这会导致错误结果的风险，FDA于5月对Cue的COVID-19测试发出警告。其中包括其家庭和非处方药（OTC）的使用以及针对患者护理环境的测试。。

By the end of May, Cue Health filed for Chapter 7 bankruptcy..

5月底，Cue Health公司申请了第7章破产。。

Cue Health’s test kit runs on the Cue Reader and includes a single-use COVID-19 cartridge and Cue Wand. The test requires no mixing of fluids or complex testing and was designed to eliminate the need to send samples to a lab, hire healthcare professionals, or perform additional confirmatory tests.

Cue Health的测试套件在Cue阅读器上运行，包括一次性使用的COVID-19墨盒和提示棒。该测试不需要混合液体或进行复杂的测试，旨在消除将样品送至实验室，聘请医疗保健专业人员或进行其他确认测试的需要。

The FDA now considers the Cue Health recall Class II, issued when the use of a product may cause a temporary or medically reversible adverse health consequence, or where the probability of serious adverse health consequences is remote. According to the agency, on Oct. 9, it revoked the EUAs for both of Cue Health’s test kits..

美国食品和药物管理局现在考虑Cue Health recall Class II，该产品的使用可能导致暂时或医学上可逆的不良健康后果，或者严重不良健康后果的可能性很小。据该机构称，10月9日，该机构撤销了Cue Health两款测试套件的EUAs。。