A recent recall of at-home COVID-19 tests raises questions about their reliability, fueling skepticism over the ongoing pandemic measures.
The Food and Drug Administration (FDA) has recalled a certain at-home testing brand, casting doubt on the reliability of these tests and emphasizing the need for caution in our battle against the virus.
The SD Biosensor, Inc. Pilot COVID-19 At-Home Tests, distributed by Roche Diagnostics, have been deemed a potential health risk as the FDA warns that these tests could lead to bacterial infections. According to the FDA’s new release, 44 affected lot numbers have been identified, and the administration advises that these tests should be disposed of immediately.
Having been distributed to both CVS Health and Amazon, approximately 516,000 tests are now under scrutiny. The FDA has confirmed that none of these recalled tests were supplied by the federal government through their COVID.gov/tests initiative or any other testing program.
Those who have purchased kits with the affected lot numbers should dispose of the entire kit and avoid exposure to the liquid solution. The FDA’s warning highlights that the liquid in these lots has been contaminated with various bacteria, including Enterococcus, Enterobacter, Klebsiella, and Serratia species.
Furthermore, the FDA has emphasized that the tests may yield inaccurate results, with both false negatives and false positives being possible outcomes. In light of this, they recommend that doctors who have used the test within the past two weeks have their patients re-tested.
Roche, in a statement, revealed that SD Biosensor Inc. identified the issue during routine quality assurance testing, where potentially harmful bacteria were found in the liquid buffer solution. The problem is believed to have originated from raw materials supplied by one of their vendors.
Despite no confirmed illnesses or performance issues reported to date, this recall raises significant concerns about the efficacy of at-home COVID-19 tests. Earlier this year, over 56,000 COVID-19 antigen rapid tests were recalled due to the lack of performance evaluation by the FDA.
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 https://t.co/xb6GXGrOv8 pic.twitter.com/Ub9evKKHaJ
— U.S. FDA Recalls (@FDArecalls) May 5, 2023
As we face the ongoing challenges of the COVID-19 pandemic, this recall serves as a reminder that we must remain vigilant and cautious in our approach. At-home testing, while convenient, may not always be the most reliable method of detecting the virus. It is essential that we continue to prioritize the health and safety of our communities by using trustworthy testing methods and taking appropriate preventive measures.