The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death.
The devices described in this recall notice are the same devices announced in the FDA safety communication: Do Not Use Certain SD Biosensor Pilot COVID-19 At-Home Tests.
- Product Names: Pilot COVID-19 At-Home Tests
- Product Codes: See Safety Communication
- Distribution Dates: August 2022 to March 2023
- Devices Recalled in the U.S.: 2,712,767
- U.S. Government: 2,147,646 kits
- CVS Health: 542,783 kits
- Amazon.com Services, Inc: 22,032 kits
- Pfizer, Inc: 306 kits
- Date Initiated by Firm: March 31, 2023
The SD Biosensor Pilot COVID-19 At-Home Test is a lateral flow immunoassay device intended for the qualitative detection of the nucleocapsid protein antigen found in the SARS-CoV-2 virus.
This test is authorized for non-prescription home use, self-collected anterior nasal (nares) swab samples from individuals aged 14 years or older, or adult collected anterior nasal (nares) swab samples from individuals aged 2 years or older.
Reason for Recall
SD BioSensor, Inc. is recalling certain Pilot COVID-19 At-Home Test kits, distributed by Roche Diagnostics in U.S. Roche packaging, after finding that the liquid solution in the test kit may be contaminated with bacteria such as Enterococcus, Enterobacter, Klebsiella and Serratia.
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.
Use of the affected product may cause serious adverse health consequences or death.
SD Biosensor, Inc. has received no complaints or reports of injuries, deaths, or adverse events.
Who May be Affected
- Anyone who may have received affected lots of SD Biosensor Pilot COVID-19 At-Home Tests from one of the sources listed above.
- People who performed a test or were tested for SARS-CoV-2 using the SD Biosensor Pilot COVID-19 At-Home Test.
- Health care providers and other organizations who cared for people tested for COVID-19 using the SD Biosensor Pilot COVID-19 At-Home Test.
Importantly, none of the impacted lots were distributed through COVID.gov/tests - Free at-home COVID-19 tests or as part of other federal testing programs.
What to Do
On May 4, 2023, SD Biosensor, Inc. issued a press release advising consumers to take the following actions:
- Immediately stop using specific Pilot COVID-19 At-Home Tests, which can be identified by the lot number on the outer packaging.
- Dispose of the entire test kit in the household trash. Do not pour the liquid down the drain.
The FDA’s Safety Communication also offered recommendations for affected parties including:
- Test users and caregivers
- Watch for signs of bacterial infection caused by exposure to the contaminated liquid solution. If you see signs of infection, such as fever, discharge, red eyes, or any other concerning symptoms, seek medical attention.
- Talk to your health care provider if you think you were tested with an affected Pilot COVID-19 At-Home Test, or if you have concerns about your test results.
- Health care providers and testing program organizers:
- If an antigen test was performed less than two weeks ago using the Pilot COVID-19 At-Home Test, consider retesting your patients using an FDA authorized or cleared SARS-CoV-2 diagnostic test if you suspect an inaccurate result. If testing was performed more than two weeks ago and there is no reason to suspect current SARS-CoV-2 infection, it is not necessary to retest.
- If a patient presents with signs of bacterial infection, such as fever, conjunctivitis, or other signs or symptoms of systemic infection, consider whether they have recently used a Pilot COVID-19 At-Home Test. If they have, consider whether their infection may be from exposure to the contaminated buffer solution.
Customers with questions about this recall should contact Roche Customer Support Center at 1-8666-987-6243 and selecting option 1. Information is also available on Roche’s website: Pilot COVID-19 At-Home Test Voluntary Recall (roche.com).
- Medical Device Recall Database entry
- FDA Safety Communication: Do Not Use Certain SD Biosensor Pilot COVID-19 At-Home Tests
- Company Press Release: Recall Notice - SD Biosensor, Inc. Requests Discontinuation of Use and Disposal of Specific Pilot COVID-19 At-Home Tests in the United States Due to Microbial Contamination in the Liquid Buffer Solution
How do I report a problem?
Health care professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program, using an online form, regular mail, or FAX.