Nearly 200,000 COVID-19 rapid test kits recalled due to false positive issues

Ellume is recalling nearly 200,000 rapid home COVID-19 antigen tests over concerns over an unusually high rate of false positives seen from some batches of his tests.

About 427,000 test kits, including thousands sent to retailers and some supplied to the Department of Defense, have been affected by the problem.

Approximately 195,000 of these kits remain unused and subject to recall. About 202,000 have already been used, the company said. Of these, there were approximately 42,000 positive results, of which up to a quarter of these positives could have been inaccurate. However, the company said it was difficult to determine an exact ratio.

Ellume is removing the affected product from store shelves and distributors should cease distribution and quarantine these products immediately.

This recall is pulling hundreds of thousands of rapid COVID-19 tests from the shelves at a time when demand for these tests has already skyrocketed. Amid the shortages, many large retail pharmacies have announced they are limiting purchases to deal with supply constraints.

Meanwhile, Ellume is advising consumers, retailers and distributors affected by the recall. It is warning consumers who have tested positive to take confirmatory testing because their initial Ellume results may have been incorrect.

Ellume CEO Sean Parsons apologized for the incident, acknowledging how accurate the test results were during this pandemic.

“We understand that trust is essential to achieving our goal as a company, and we recognize that this incident may have shaken the confidence of some of those who trusted Ellume to help them manage their health. and to regain some control of their lives during this pandemic, ”Parsons said in a statement. “To these people, I offer my sincere apologies – and the apologies of our entire company – for any stress or difficulty they may have experienced due to a false positive result.”

“You have my personal commitment which we have learned from this experience, we have put in place additional controls to make sure our product meets our high quality standards and we will do everything in our power to regain your trust “Parsons said in the statement.

Ellume said he identified the root cause as a variation issue with one of the components in his test kit, and said he “implemented additional controls” and “continue to work to resolve the issue that led to this reminder “.

Although the recall was triggered by false positives, the company said the reliability of negative results from its kits is not affected by this issue: approximately 160,000 tests from affected lots produced negative results.