MagNA Pure 24 System, GMMI: 07290519001 Product Usage: The MagNA Pure 24 System is a fully automated clinical sample extractor. It extracts nucleic acids from various sample types, sample tubes, and volume inputs for multiple downstream applications. The main features of the system are : Scalable pu
Check against the official notice below — it lists the full affected range.
Roche Molecular Systems, Inc. is recalling the MagNA Pure 24 System (Model GMMI: 07290519001), an automated clinical sample extractor used to extract nucleic acids from patient samples. The recall was initiated because cross-contamination of samples has been reported when running the existing protocol on the system with rack-based purification runs. A total of 163 units have been affected by this recall.
The recalled devices were distributed worldwide, including to multiple U.S. states (California, Georgia, Hawaii, Indiana, Maryland, Maine, Michigan, Minnesota, North Carolina, New York, Pennsylvania, Virgin Islands, and Wisconsin) and numerous foreign countries including Austria, Belgium, Brazil, Chile, China, Colombia, Costa Rica, Czech Republic, Denmark, France, Germany, Guatemala, Hong Kong, Hungary, India, Israel, Italy, Japan, Mexico, Netherlands, Norway, Poland, Singapore, and Slovenia. The source record does not specify a remedy or recommended action for affected consumers.
Written by software from the official notice below. Not reviewed by a lawyer.
Cross-contamination of samples has been reported when running the existing protocol on the system with the rack-based purification run.
Reason for recall: Cross-contamination of samples has been reported when running the existing protocol on the system with the rack-based purification run. Distribution: Worldwide Distribution - US Nationwide in the states of: CA, GA, HI, IN, MD, ME, MI, MN, NC, NY, PA, VI, and WI. The products were distributed to the following foreign countries: Austria, Belgium, Brazil, Chile, China, Columbia, Costa Rica, Czech Republic, Denmark, France, Germany, Guatemala, Hong Kong, Hungary, India, Israel, Italy, Japan, Mexico, Netherlands, Norway, Poland, Singapore, Slovenia, Quantity: 163 units Lot/code info: Device Identifier: 07613336106174
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.