The FDA found one Covid test manufacturer altered their product after they'd gained government approval. Here's what to do if you have it at home.
250,000 Covid Tests Sold Nationwide Recalled for False Results
Published on Oct. 16, 2024
As we enter virus season, staying on the lookout for symptoms is wise, as well as considerate. Preventing the spread can save lives.
Taking a Covid test when you present with early possible signs is still one of the best ways to avoid passing the respiratory illness to others—so helpful that national authorities have made Covid tests available at no cost again. Whichever Covid tests you have in your cabinet or closet, check your test’s label to ensure that it’s up to snuff.
Here’s why: A widely used Covid test, made by San Diego-based Cue Health, recently came under fire when it was discovered to produce false results, putting people at risk of unknowingly spreading their Covid infections. The U.S. Food and Drug Administration (FDA) initially issued a recall of 248,109 units of the at-home Covid test kits on May 13, 2024. However, they more recently published an October 15 update stating that the incident is now considered a class II recall—one that could cause “adverse health consequences.”
The lot codes on the recalled Cue tests are the following, according to the FDA:
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
A May 9 inspection letter from the FDA to the company explains that the products had been modified without FDA oversight after they were initially granted emergency use authorization (EUA) in 2020. “Evidence obtained during the inspection demonstrated that your firm implemented several changes to your EUA-authorized devices and implemented those changes without authorization from FDA pursuant to the Conditions of Authorization,” the FDA wrote. “These modifications may negatively impact the stability of the devices, resulting in failure earlier than the 9 months claimed on the product labeling,” the FDA later states in the letter.
Shortly after the inspection letter was issued, Cue Health filed for bankruptcy and began shutting down its operations. At the height of its success, the company was considered pivotal in the effort to make at-home PCR tests accessible to the public, at one point boasting a $3 billion valuation.
Given an “increased risk of false results,” the FDA is now urging consumers to discard all home-test kits made by Cue Health. If you tested negative for Covid using a Cue Health Covid test within the last two weeks, retest with an FDA-approved brand and discuss your concerns with your doctor, they advise.
If you believe you have been adversely affected by this or any other at-home Covid test, the FDA encourages you to report the problem through the MedWatch Voluntary Reporting Form. (Editor’s note: The image used in this article does not specifically represent the packaging of the recalled Covid tests.)
For daily wellness updates, subscribe to The Healthy by Reader’s Digest newsletter and follow The Healthy on Facebook and Instagram. Keep reading:
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