San Diego, CA: Kurin Inc., the inventor and manufacturer of 510(k)-cleared Kurin® blood culture collection sets, has sued Magnolia Medical Technologies in the U.S. District Court for the Southern District of California for violations of the Lanham Act based on its false and misleading statements. In the suit, Kurin alleges that Magnolia falsely implies that its Steripath device is FDA approved/cleared, and misrepresents product performance data by selecting only the most favorable results.
“Making claims about medical product performance is under the purview of the US Food and Drug Administration. In this case, the FDA has not cleared Steripath for marketing, so making such claims is irresponsible,” said Bob Rogers, CEO of Kurin. “We have a responsibility to accurately portray the ability of medical devices to improve clinical outcomes. Magnolia has abused this principle, confusing healthcare providers.”
Kurin offers an initial specimen diversion technology that automatically and passively diverts potential contaminants during blood culture collection. When skin microbes enter into blood culture samples, false positive test results may misinform physicians and lead to unnecessary medical treatment and risk for patients and significant costs for the hospital.
Kurin’s patented automatic blood diversion product is the only FDA 510(k)-cleared blood culture diversion product on the market. The Kurin comprehensive product suite includes 21g and 23g butterfly safety needles, a PIV connector for use with IV Starts, and culture bottle holders compatible with BD Bactec®, BioMerieux BacT/Alert®, and ThermoFisher VersaTREK™ REDOX™ bottles.
“We strive to present data that accurately reflect the impact of initial specimen diversion in hospitals. Magnolia claims ‘virtual elimination of false positives’ based on studies that do not reflect actual conditions in the hospital including non-compliance due to deficiencies in their product design. In the real world, there are commonly used procedural exceptions that cannot be ignored when evaluating true product efficacy. To knowingly do so is misleading,” said Rogers.
About Kurin, Inc.
Kurin Corporation, a certified Minority Business Enterprise (MBE), is focused on the design, development, manufacture, marketing, and sale of products that help healthcare providers reduce contaminated blood cultures. San Diego-based Kurin has received FDA 510(k) market clearance. For more information, visit the website at www.kurin.com.