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Publication date: May 4, 2023
The U.S. Food and Drug Administration (FDA) has advised consumers and healthcare providers to stop using recalled lots of SD Biosensor, Inc. pilot COVID-19 at-home tests distributed by Roche Diagnostics, I warn you to throw it away. The FDA has serious concerns about bacterial contamination of the Pilot COVID-19 At-Home Test liquid solutions contained in test kits. Direct contact with contaminated solutions can pose a safety issue, and bacterial contamination can affect test performance.
SD Biosensor, Inc. has initiated a recall of all affected SD Biosensor Pilot COVID-19 home tests distributed by Roche Diagnostics to select US retailers. About 500,000 tests were distributed to CVS Health and about 16,000 tests were distributed to Amazon. The FDA is working with Roche Diagnostics to understand how many of these tests have been sold to consumers.
Importantly, none of the affected lots were distributed through COVID.gov/tests as part of free home testing for COVID-19 or other federal testing programs. Thing. If you received your tests through the COVID.gov/tests distribution or as part of any other federal testing program, they are not subject to this safety notice or product recall.
FDA advises consumers to discontinue use and discard the following lot number pilot COVID-19 home test kits:
| 53K38N1T1 | 53K4221T1 | 53K4292T1 |
| 53K38N2T1 | 53K4222T1 | 53K42A1T1 |
| 53K38N3T1 | 53K4223T1 | 53K42A2T1 |
| 53K38N4T1 | 53K4224T1 | 53K42A3T1 |
| 53K38N5T1 | 53K4225T1 | 53K42E1T1 |
| 53K38P1T1 | 53K4231T1 | 53K42G1T1 |
| 53K38P2T1 | 53K4232T1 | 53K42G2T1 |
| 53K38P3T1 | 53K4233T1 | 53K42H1T1 |
| 53K41T5T1 | 53K4261T1 | 53K42H2T1 |
| 53K41X1T1 | 53K4262T1 | 53K42L1T1 |
| 53K41X2T | 53K4271T1 | 53K42L2T1 |
| 53K41X3T1 | 53K4272T1 | 53K4361AC |
| 53K4211T1 | 53K4273T1 | 53K4362AC |
| 53K4212T1 | 53K4274T1 | 53K4392AC |
| 53K4213T1 | 53K4291T1 |
Recommendations for consumers, test users and caregivers
- Compare lot numbers to see if the SD Biosensor Pilot COVID-19 Home Testing is included in the SD Biosensor product recall.
- Do not use test kits with affected lot numbers listed above. Discard the entire test kit in your household trash. Do not pour the solution down the drain. Additional information can be found in the Quick Reference Instructions for Patients.
- If the liquid in the tube comes in contact with your skin or eyes, flush with plenty of water. If irritation persists, seek medical attention.
- Watch out for signs of bacterial infection caused by exposure to contaminated solutions. Seek medical attention if you have signs of infection such as fever, discharge, red eyes, or other symptoms of concern.
- If you believe you have been tested for COVID-19 at home by an affected pilot, or if you have any concerns about your test results, please consult your healthcare provider.
Recommendations for Healthcare Providers and Testing Program Organizers
- If an antigen test is performed within 2 weeks using a pilot COVID-19 home test, if inaccurate results are suspected, the patient should be tested using an FDA licensed or approved SARS-CoV-2 Please consider rechecking. If the test was performed more than 2 weeks before him and there is no reason to suspect current SARS-CoV-2 infection, there is no need to retest.
- Consider whether a pilot COVID-19 home test has recently been used if the patient has signs of bacterial infection such as fever, conjunctivitis, or other signs and symptoms of systemic infection. If infected, consider whether the infection was due to exposure to contaminated buffers.
- Report any issues you encounter with pilot COVID-19 home testing, including suspected erroneous results, to FDA. See Reporting Test Problems.
potential risk
The liquid solution contained in the Pilot COVID-19 home test kit for affected pilots is contaminated with microorganisms such as Enterococcus, Enterobacter, Klebsiella and Serratia species It has been found. The person doing the self-test is at risk of direct contact with the contaminated liquid in the tube. Liquids are contained in individual, pre-filled and sealed tubes ready for use, but the user should not accidentally contaminate them while opening the tube, handling an open tube, or performing a test. direct contact with liquid buffers.
Infections by bacteria such as Enterococcus, Enterobacter, Klebsiella, and Serratia spp. can occur in immunocompromised individuals or by direct exposure to contaminated solutions through standard handling, accidental spillage, or misuse of the product. can cause illness in humans.
In addition to the risk of infection, this contamination can affect test performance and lead to erroneous results.
- False negative antigen test results This means that the test says the person does not have COVID-19, but in fact they do. False-negative results can lead to delayed diagnosis and inappropriate treatment of SARS-CoV-2, which can cause harm, including serious illness and death. False-negative results can also lead to further spread of the SARS-CoV-2 virus, such as when people are housed together in medical facilities, long-term care facilities, and other facilities because of false test results. . Measures to limit contact with infected people, such as quarantining people, limiting contact with family and friends, and restricting access to the workplace in the event of a false-negative test result. may not be taken.
- False-positive antigen test results This means that a test shows that the person has COVID-19, but they actually do not have COVID-19. False-positive results can lead to delays in both correct diagnosis and appropriate treatment for the actual cause of a person’s illness, which could be another life-threatening illness that is not COVID-19. I have. False-positive results can also lead to further spread of the SARS-CoV-2 virus when presumed-positive people are housed together.
To date, FDA has not received any reports of injuries, adverse health effects, or deaths associated with the use of the SD Biosensor Pilot COVID-19 Home Test.
test description
The SD Biosensor Pilot COVID-19 At-Home Test is a lateral flow immunoassay device for the qualitative detection of nucleocapsid protein antigens contained in the SARS-CoV-2 virus. The test is available for non-prescription home use, self-collected anterior nasal (nostril) swab samples from individuals 14 years of age or older, or adult anterior nasal (nostril) swab samples from individuals 2 years of age or older. Authorized.
FDA action
The FDA is currently reviewing a recall of the SD Biosensor pilot’s COVID-19 home testing and is in the process of classifying recall risks. The FDA continues to work with SD Biosensor Inc. to assess the company’s corrective actions to address the source of the bacterial contamination and ensure the situation is resolved and does not recur.
FDA will continue to keep the public informed of important new information.
Report device issues
If you believe you have had a problem with the SD Biosensor pilot’s COVID-19 home testing, FDA encourages you to report the problem through the MedWatch Voluntary Reporting Form.
In general, device manufacturers must comply with applicable Medical Device Reporting (MDR) regulations, as specified in the Emergency Use Authorization for Testing.
do you have any questions?
If you have any questions, please email the Department of Industry and Consumer Education (DICE) at DICE@FDA.HHS.GOV or call 800-638-2041 or 301-796-7100.