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. Consumers who have Pilot COVID-19 At-Home Test kits from affected lot numbers should follow the instructions below to obtain replacement kits.
To request a replacement for a specific Pilot COVID-19 At-Home Test Kit with one of the affected lot numbers, please complete and submit the form below or call the Roche Customer Support Center at 1-866-987-6243 and select option 1.
For more information, please view MedWatch Online Voluntary Reporting Form (fda.gov). This action is being taken with the knowledge of the FDA.