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. Consumers who have Pilot COVID-19 At-Home Test kits from affected lot numbers should follow the instructions below to obtain replacement kits.

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.

Enter your lot number:

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

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Obtaining a replacement test

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.

If you have more than one kit affected, you will need to complete the form once for each kit you have.

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

How was the Pilot™ COVID-19 At-Home Test Kit issue identified and what is the nature of the contamination?

SD Biosensor Inc., 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 inside the tube of 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 is ongoing. Roche and SD Biosensor have worked closely with the FDA to ensure any further action required is taken as quickly as possible.

How do you know other lots/kits are not affected?

SD Biosensor Inc. has conducted testing on all currently available and 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.

If the consumer has used a test not part of the affected batch, how do they know that it is safe to continue using?

Consumers may look up their test kit’s lot number on this page, which will indicate whether a particular test kit may be used or should be properly disposed of. Consumers may also contact the Roche Customer Support Center at 1-866-987-6243 and select option 1. If a consumer’s test kit is from an unaffected lot, 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 consumer has spilled the liquid in the tube on their hands, or the liquid has gotten in their eyes, nose or mouth. What should they do?

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 Help line, 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.

How does the consumer clean up/remove the liquid that was in the tube from a surface if it spilled?

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.

How does the consumer identify that they purchased a product from an affected lot, and how do they receive a replacement product?

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 on this page, or by contacting the Roche Customer Support Center at 1-866-987-6243 and selecting option 1. They also can view our latest updates, including follow-up actions and potential replacement.

When will consumers receive their replacement kits?

We are working closely with SD Biosensor Inc. to establish production and delivery timelines for replacement product and will provide new, unaffected kits as soon as possible.

What should consumers do if they need to test now? What is Roche doing to help those affected consumers?

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