First recalled in Oct. due to the chance of false positive COVID-19 home tests, medical diagnostics manufacturer Ellume recalled more than 2 million of the tests due to higher than acceptable false positives.
Announced by the U.S. Food and Drug Administration (FDA) on Wednesday, the Ellume home COVID-19 test is listed as a Class I recall, or the most serious type of recall, due to the impact it could have on the health of those who receive false positives. In particular, patients with a false positive COVID-19 test may stop trying to figure out what is really making them ill and may also receive unnecessary COVID-19 treatments, the FDA stated. In addition, people with false positive tests are likely to disregard precautions against COVID-19, such as vaccinations.
The recalled tests were manufactured between Feb. 24 and Aug. 11 and distributed between April 13 and Aug. 26. So far, there have been 35 reports of false positives and no reported deaths as a result of the Ellume home COVID tests, the FDA said.
The FDA statement said the agency is working with the manufacturer to determine what has caused the problem and prevent problems going forward.
The likelihood of more than 35 false positives is high if the manufacturer recalled 2 million tests. Because the health consequences of this kind of misinformation are serious, those who used the tests and received a positive result may want to speak to a lawyer. The Philadelphia defective medical products lawyers at Brookman, Rosenberg, Brown & Sandler are ready to help. Call 215-569-4000 or complete an online form for a free consultation. Located in Philadelphia, the firm serves clients in Delaware County, Chester County, Philadelphia County, Pennsylvania and New Jersey.