SD Biosensor Inc., the manufacturer of the Pilot™ COVID-19 At-Home Test, is requesting that consumers stop using and properly dispose of test kits from 44 specific lots in the United States because potentially harmful bacteria were found in the tube with liquid inside (pouch 2 of the kits). The affected tests, which can be identified by the lot number on the outer packaging, should be appropriately discarded. Dispose of the entire test kit in the household trash. Do not pour the liquid down a drain.
We are no longer accepting replacement requests because all affected product lots expired on August 16, 2023.
For more information, please view MedWatch Online Voluntary Reporting Form (fda.gov). This action is being taken with the knowledge of the FDA.