The company is also pulling 61,500 Clean Catch Urine Kits, which are used for testing for conditions such as urinary tract infections, according to the FDA.
Because the facility did not meet regulations, the products could result in false positives or false negatives. As of July 20, there have been no complaints filed.
At the Becker's 11th Annual IT + Revenue Cycle Conference: The Future of AI & Digital Health, taking place September 14–17 in Chicago, healthcare executives and digital leaders from across the country will come together to explore how AI, interoperability, cybersecurity, and revenue cycle innovation are transforming care delivery, strengthening financial performance, and driving the next era of digital health. Apply for complimentary registration now.