the staff of the Ridgewood blog
Ridgewood NJ, The FDA has issued a recall for additional batches of Australia-based company Ellume’s at-home COVID-19 test kits for potentially false-positive results. This recall is for the same issue that was previously reported in early October and classified as a Class I recall, the most serious recall designation that may result in “serious adverse health consequences or death.” Product batches with a manufacture date between February 24 and August 11, 2021, and distribution dates between April 13 and August 26, 2021, are included in the recall, which includes more than 2.2 million of the 3.5 million tests shipped to the US; Ellume’s previous estimate of faulty tests was 427,000. Those who attempt to use the affected tests will be notified through the app of the recall status, and replacement tests can be requested online. Thus far, the FDA has received reports of 35 false positives from the tests.
The Biden administration made a $231.8 million deal with Ellume in February to boost availability of the at-home testing kits in the US, which also helped fund the company’s first manufacturing plant in the US in Frederick, Maryland, with a 500,000 test production capacity per day. The White House made an additional $1 billion allocation for the purchase of the 8 types of at-home testing kits available in the US shortly after the first Ellume recall was publicized.