SD BioSensor Inc. is recalling certain Pilot COVID-19 At-Home Test kits, distributed by Roche Diagnostics in the United States, after finding that the liquid solution in the test kit may be contaminated with bacteria such as Enterococcus, Enterobacter, Klebsiella, and Serratia. The FDA has identified this as a Class I recall, the most serious type of recall.
Infection from these bacteria species may cause illness in people with weakened immune systems or those with direct exposure to the contaminated liquid solution through standard handling, accidental spills, or misuse of the product. In addition to the risk of infection, this contamination may impact the performance of the test, and false results may occur.
According to the FDA, SD Biosensor Inc. has received no complaints or reports of injuries, deaths, or adverse events since initiating the recall March 31, 2023.
None of the impacted lots of this Pilot COVID-19 At-Home Test were distributed through COVID.gov/tests – Free at-home COVID-19 tests or as part of other federal testing programs. The affected test kits were distributed between August 2022 and March 2023 by Roche Diagnostics to distributors and retailers in the United States. For specific lot numbers of affected tests, see the FDA safety communication.
On May 4, 2023, SD Biosensor issued a press release advising consumers to immediately stop using the possibly contaminated Pilot COVID-19 At-Home Tests and to dispose of the entire test kit in the household trash.
Information about this voluntary recall is also available on the Roche website.