Using a COVID-19 home test? Make sure it’s not one of these recalled tests; hundreds have been recalled in Guilford County

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(WGHP) — With Christmas and holiday travel on the horizon, more people are turning to home COVID-19 tests to make sure they’re good to go.

You may want to be careful, however, as a batch of Elume-brand home tests have been recalled and may not provide accurate results.

Some of the hundreds of COVID tests given out in Guilford County on Tuesday have been recalled.

Use this tool on the Ellume COVID test website to find out if your test is affected by this recall.

Anyone who purchased a recalled test can request a replacement by using the form on the Ellume website.

Tests were given out at the Guilford County Department of Social Services on Maple Street in Greensboro and the Roy Culler Jr. Senior Center on Eastchester Drive in High Point.

Guilford County Public Health Director Iulia Vann says the North Carolina Department of Health and Human Services gave them to Guilford County after getting them from the federal government.

The Ellume tests are supposed to provide results within 15 minutes.

On Oct. 5, the Food and Drug Administration recalled certain lots of Ellume COVID-19 Home Tests. The company says that these specific batches of tests have “higher-than-acceptable false positive test results for SARS-CoV-2.” There have been 35 reports of false positive results sent to the FDA.

Negative results from the tests are not affected.

This means that anyone who uses one of these particular Ellume COVID-19 home tests may get a positive test when they are actually negative.

The recall was initially for more than 400,000 tests. That number later jumped to about 2 million as Ellume gathered additional information.

The tests are app-based. If the company finds a lot that needs to be recalled, they auto-update, and the update goes to the app.

That means people in NC who got one of the tests are being told their test has been recalled.

NC health officials say if your test comes back positive instead of recalled, you should get a PCR test. But if your test comes back negative, that result is said to be accurate.

The FDA takes this kind of defect very seriously, categorizing this recall as “Class I,” the most serious type of recall. The FDA says using these tests may cause serious adverse health consequences or death. A false positive could lead to delayed treatment, further spread of the virus and/or unnecessary COVID-19 treatments.

As of Dec. 16, the FDA lists this as the only active recall for COVID-19 home tests.

The NCDHHS released the following statement:

Earlier this year, Ellume test kits were voluntarily recalled by the manufacturer because some batches were displaying false positive results.  Today, 500 Ellume home test kits were distributed in Guilford County at two curbside pick-up locations between 2pm and 5pm. Unfortunately, some of the test kits were impacted by the voluntary recall. Ellume tests use a smartphone app that notified people if their test kit was recalled. So if a test was recalled, the person will not be able to complete the testing process.  If the test functioned, there is no issue with the test. For anyone that finds their kit recalled, please refer to a multitude of COVID-19 testing options online at www.HealthyGuilford.com or www.ncdhhs.gov/gettested.   Many of these locations offer rapid antigen tests. NCDHHS and the Guilford County Division of Public Health regret this inconvenience.

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