Hundreds of thousands of at-home Covid test kits have been recalled after they were found to contain dangerous bacteria.
SD Biosensor Inc. Pilot COVID-19 At-Home Tests are being recalled amid a warning from the Food and Drug Administration (FDA).
According to the FDA, the tests, distributed by Roche Diagnostics, could lead to a bacterial infection.
Anyone in possession of one of these test kits is being urged to throw it away, according to a new release on the FDA’s website.
The FDA website lists 44 affected lot numbers.
About 500,000 tests were distributed to CVS Health, the FDA reported.
Another 16,000 tests were distributed to Amazon.
The FDA said it is not clear how many units were sold in total.
None of the tests that have been recalled were distributed by the federal government or any other testing program, the FDA said.
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
According to the FDA warning, anyone who bought a kit that has the affected lot numbers listed on the FDA website should throw the entire kit in the trash.
The FDA warns against exposure to a liquid solution in the kit and said that if contact takes place between the liquid and either skin or eyes, the point of contact should be flushed with water.
The liquid in the affected lots has been contaminated with organisms such as Enterococcus, Enterobacter, Klebsiella, and Serratia species of bacteria.
Although the liquid is in a tube in the kits, contact is possible while using the kit.
The FDA wanted that infection from the bacteria “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.”
However, the bacteria contamination wasn’t the only issue with the kits.
The FDA revealed that the test results may also be inaccurate.
Both false negative tests, in which the person has COVID-19 but it is not detected, and false positives, in which an individual does not have COVID-19 but is shown on the test to be infected, are possible, the FDA warned.
The FDA also advised doctors who have used the test within the past two weeks to have the individual re-tested.
“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 buffer solution,” Roche said in a statement, according to CBS.
Evie Baik, a representative of SD Biosensor, said in a statement that the infection stems from an issue with raw materials from a supplier.
“To date, no such illness has been reported and to date, no impact on performance has been confirmed,” Baik said.
This is not the first recall of the year for at-home COVID-19 tests, according to Fox Business.
In February, more than 56,000 COVID-19 antigen rapid tests were recalled.
The Skippack Medical Lab SARS-CoV-2 Antigen Rapid Test Kits produced by Universal Meditech Inc., “potentially could result in inaccurate test results due to lack of performance evaluation by the FDA,” the recall notice said.
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