Pilot COVID-19 At-Home Test Voluntary Recall

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.

 

Look up your test kit’s lot number

Enter the lot number for your test kit to learn if it is affected by this voluntary recall. If use-by dates appear, your test kit is unaffected. If red “Recalled” messages appear, your test kit is affected and should be properly discarded.

Watch this video to find the lot number, buffer number and manufacturing date for your test kit.
How to find your lot number, buffer number and manufacturing date

For additional info

  • View SD Biosensor’s press release about the voluntary recall of select lots of the Pilot COVID-19 At-Home Test in the U.S.
  • If you have questions or concerns about the Pilot COVID-19 At-Home Test, please call the Roche Customer Support Center at 1-866-987-6243 and select option 1.
  • If you have health-related questions or concerns, please contact your physician or healthcare provider.
  • To discard affected tests: Dispose of the entire test kit in the household trash. Do not pour its liquid down the drain. 
  • You also may report adverse events such as unexpected side effects or injury or product quality problems by calling the Roche Customer Support Center at 1-866-987-6243 and selecting option1, or via the U.S. Food and Drug Administration’s (FDA’s) MedWatch Adverse Event Reporting program in the following ways:
    • Online: Complete and submit a report on this FDA webpage.
    • Standard mail or fax: Download this form or call 1-800-332-1088 to request a form. Then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178.

For more information, please view MedWatch Online Voluntary Reporting Form (fda.gov). This action is being taken with the knowledge of the FDA.

Frequently asked questions

Frequently asked questions

SD Biosensor, the manufacturer of the Pilot COVID-19 At-Home Test, informed Roche that this issue was identified during routine quality assurance testing. Potentially harmful bacteria were found in the liquid buffer solution (liquid inside pouch 2 of the kits), in specific lots of Pilot COVID-19 At-Home Tests sold in the U.S. With a direct focus on patient safety, Roche, as the exclusive distributor of these test kits in the U.S. market, immediately informed all distributors and retailers who received the affected lots and asked them to quarantine those lots at the distributor level while the investigation was ongoing. SD Biosensor requested that consumers stop using and properly dispose of test kits from the 44 specific lots in the U.S. The affected tests, which can be identified by the lot number on the outer packaging, should be appropriately discarded. Roche and SD Biosensor worked closely with the FDA to ensure required actions were taken as quickly as possible. 

SD Biosensor conducted testing on unexpired lots in the market. The testing indicated that contamination is isolated to the lots identified in the press release, and no additional affected lots have been identified.

Consumers may look up their test kit’s lot number on this page, which will indicate whether a particular test kit was part of the affected batch and should be properly disposed of. Consumers may also contact the Roche Customer Support Center at 1-866-987-6243 and select option 1. Do not use the test if the expiration date has passed. If a consumer’s test kit is from an unaffected lot and hasn’t expired, it is safe to continue using tests from that kit in accordance with the instructions for use, which can be found in the test kit or at go.roche.com/covid-home-test. The expiration date can be found on the box label.

If the liquid in the tube comes in contact with skin or eyes, flush them with large amounts of water. If irritation persists, seek medical attention or call the national, toll-free Poison Helpline, 1-800-222-1222, and you will be connected to your local poison center. Please contact your physician or healthcare provider if you have any questions or concerns.

In the event of a spillage, ensure the area of the spill is cleaned thoroughly using a suitable disinfectant and wash your hands thoroughly with soap and water.

Individuals who have purchased a Pilot COVID-19 At-Home Test in the U.S. are encouraged to check if their test has been affected via the lot-lookup tool above and on this page, or by contacting the Roche Customer Support Center at 1-866-987-6243 and selecting option 1. Replacement requests are no longer being accepted because all affected product lots expired on August 16, 2023.

Tests can be purchased online or in select pharmacies nationwide. Visit the FDA’s website (fda.gov) for a list of authorized tests.