The US Food and Drug Administration (FDA) has issued a recall notice for over 500,000 at-home Covid-19 test kits distributed by Roche Diagnostics through the pharmacy chain, CVS Health, and the online retailer, Amazon. These tests, manufactured by South Korea’s SD Biosensor, contain a test solution that may be contaminated with potentially harmful bacteria. The FDA has warned that direct contact with the test solution could pose safety risks and compromise accuracy, adding that people with weakened immune systems are particularly at risk of infection.
The affected test kits, known as the Pilot Covid-19 At-Home Tests, feature two separate pouches containing necessary chemicals and testing equipment. The contaminated liquid is contained in the test solution’s pouch, which is used to release a sample’s retort into the testing unit for analysis. The FDA recalls nearly 40 different lots of these kits. They hold a mix of contaminated and potentially contaminated samples, and the agency has provided an extended list of recalled kits on its website.
The FDA cautioned users and manufacturing companies not to pour the solution down the drain. The agency thoroughly tested each batch of the Pilot test kits to identify the particular strain of bacteria contaminating the test solution. Identified bacterias include Enterobacter cloacae & aerogenes, Klebsiella pneumoniae, Serratia marcescens, and Enterococcus faecalis.
There have been no reported illnesses or injuries to the public due to the infected Pilot test kits. However, users are advised against using them and to dispose of them safely. The FDA and the Centers for Disease Control and Prevention (CDC) have been at the forefront of the fight against the Covid-19 pandemic. These regulators have paved the way for the effective and safe distribution of the Covid-19 vaccine.
The distribution of the Pilot Covid-19 At-Home Tests to CVS and Amazon stores is not the first recall of these types of tests in the US. In March, the FDA issued a recall for three other at-home Covid-19 tests distributed by Innova Medical Group due to concerns about false-negative results. While these types of tests have been useful in supporting public health efforts during a global pandemic, regulators continue to stress the importance of accuracy and safety to mitigate any potential harm.
In conclusion, the recall of over 500,000 at-home Covid-19 test kits distributed by CVS and Amazon due to contamination concerns by potentially harmful bacteria is a significant and necessary cautionary step taken by the FDA. While this recall will create a need for additional testing and potential delays for those who require testing in the future, the health and safety of the public are of utmost concern. The pandemic has underscored the importance of accurate, reliable, and safe testing methods, and regulators must ensure that manufacturers adhere to rigorous safety and quality standards. The FDA’s continued vigilance in surveillance, testing, and risk assessment remains critical for the protection of public health.
