COVID tests handed out in NC county had already been recalled over false positives
A North Carolina county health department distributed 500 at-home COVID-19 test kits just before the Christmas holiday — some of which had been recalled, according to local health department officials.
The tests were handed out on Wednesday, Dec. 22, by the Guilford County Health Department, WXII reported.
Australian medical technology company Ellume manufactured the test kits, which were recalled in October over concerns about a “higher-than-acceptable” rate of false positives, the U.S. Food and Drug Administration said. More than 2 million tests distributed between April and August were affected by the recall.
Kenya Smith Godette, spokesperson for the Department of Public Health in Guilford County, told McClatchy News it was a voluntary recall and “not due to any health and safety hazards.”
The county received the test kits from the N.C. Department of Health and Human Services, Director of Public Health Dr. Iulia Vann told WFMY.
“There are no potential health hazards, and there is no reason for anyone to be concerned about their health or well-being,” Vann said.
In a statement to McClatchy News, N.C. DHHS said the test kits were distributed at two curbside pick-up locations in Guilford County between 2 and 5 p.m.
“Unfortunately, some of the test kits were impacted by the voluntary recall,” N.C. DHHS said. “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.”
The tests were available for pickup at the Guilford County Department of Social Services in Greensboro and the Roy Culler Jr. Senior Center in High Point, according to a news release from the Guilford County Division of Public Health.
Test kits were limited to four per family.
“NCDHHS and the Guilford County Division of Public Health regret this inconvenience,” N.C. DHHS said in the statement.
The app-based at-home test by Ellume uses a nasal swab to test for the virus and returns results within 15 minutes.
Ellume first noticed the high rate of false positives in September, according to its website. On Oct. 1, the company issued a voluntary recall after discovering the issue was confined to specific product lots. But it said there wasn’t a problem with negative test results.
Four days later, the FDA issued a “safety communication” alerting consumers. The agency has since identified it as a Class I recall with the potential for “serious adverse health consequences or death.”
FDA officials said the false positive could result in delayed treatment for the actual cause of the person’s illness, further spread of the virus, receiving unnecessary COVID-19 treatment, disregarding safety precautions such as getting a vaccine or missing school or work and self-isolating without reason.
Ellume provided a list of the lot numbers after it issued the voluntary recall, and N.C. DHHS — which received a large number of the at-home test kits — pulled the affected kits, Godette told McClatchy News.
But there was an additional list shared internally that wasn’t available to the public, she said.
The Guilford County Health Department started receiving calls from people who were being notified on the app that the test they were using was recalled, Godette said, prompting the county to call N.C. DHHS. State health officials then shared information about the internal list.
Godette said it wasn’t an oversight by the state health department and no one could have known those specific tests had been recalled unless they opened one and used it.
County health officials have not determined how many of the 500 tests that were distributed have been recalled.
Anyone who believes they received a recalled Ellume test can check at www.ellumecovidtest.com/returnExternal Link Disclaimer.
Godette said if someone picked up an Ellume test from the county health department at one of the two curbside locations and received a positive test, they should follow up with a PCR test to ensure the results were accurate.
This story was originally published December 23, 2021 at 3:46 PM.
