- A recall of more than 2.7 million at-home COVID-19 tests made by SD Biosensor and distributed by Roche Diagnostics was labeled Class I by the Food and Drug Administration, its highest risk category.
- Several lots of SD Biosensor’s Pilot COVID-19 At-Home Tests were recalled because the “FDA has significant concerns of bacterial contamination” in the provided liquid solution, which could pose safety concerns and affect the test’s performance.
- Users and healthcare providers should throw away the affected test kits, the FDA said in a Thursday notice. People who recently used the test should retest if they suspect an inaccurate result.
The recall includes more than 2.7 million tests distributed by Roche to the U.S. government, retailers CVS Health and Amazon, and to pharmaceutical giant Pfizer between August of last year and this March.
The only tests to reach end users were those sold by CVS and Amazon, a Roche spokesperson said in an interview. The FDA and Roche noted that none of the 2 million tests bought by the U.S. government were distributed to consumers. Roche announced the voluntary recall on May 4.
"Importantly, none of the impacted lots were distributed through COVID.gov/tests - Free at-home COVID-19 tests or as part of other federal testing programs," the FDA said in its statement.
Roche spokesperson Gina Goodenough said she could not say how much money the recall had cost Roche because a review of the incident is ongoing.
The FDA said it had not received any reports of injuries or adverse health consequences related to the test, but said the bacteria could cause illness in people with weakened immune systems or people who are exposed directly to the contaminated liquid.
In an emailed statement, Roche spokesperson Jen Dial said that SD Biosensor identified the problem during quality assurance testing. Roche informed all distributors and retailers who received the affected lots, and asked them to quarantine the tests while the investigation continues.
"Roche and SD Biosensor have worked closely with the FDA to ensure any further action required is taken as quickly as possible," Dial added.
Roche has a global distribution agreement with South Korea-based medtech company SD Biosensor, and the companies received FDA clearance for the over-the-counter COVID test in December of 2021, which Roche said was its first over-the-counter test in the U.S. It rebranded the test as Pilot in late 2022.
Last year, the companies encountered a problem where a separate COVID antigen test made by SD Biosensor that was not approved by the FDA was illegally imported into the U.S., leading to a recall and an investigation by the companies on how those products entered the country.
Last year, Roche reported sales of 4.1 billion Swiss francs (about $4.54 billion) from total sales of COVID-related tests, a 10% decrease year-over-year. Meanwhile, SD Biosensor and private equity firm SJL Partners completed a $1.53 billion buyout of Ohio-based diagnostics company Meridian Bioscience earlier this year.
This article has been updated with a clarification from Roche.