Class 2 Device Recall MagNA Pure 24 System Pathogen Protocols

• Date Initiated by Firm: May 02, 2018
• Create Date: May 30, 2018
• Recall Status: Terminated on April 30, 2019
• Recall Number: Z-1956-2018
• Recall Event ID: 79899
• Product Classification: Clinical sample concentrator - Product Code JJH
• Product: 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 purification of 1 to 24 samples Primary/secondary tube handling Inventory and sample management via barcodes Efficient order management via host The MagNA Pure 24 System offers 4 run types: Purification (rack) run Purification (cartridge) run Post Elution run Sample transfer run
• Code Information: Device Identifier: 07613336106174
• FEI Number: 2243471
• Recalling Firm/ Manufacturer: Roche Molecular Systems, Inc.; 1080 US Highway 202 S; Branchburg NJ 08876-3733
• Manufacturer Reason for Recall: Cross-contamination of samples has been reported when running the existing protocol on the system with the rack-based purification run.
• FDA Determined Cause: Software in the Use Environment
• Action: Customers were notified of the field action by letter on 4/27/18. The letter included the following required actions: " If you used the MagNA Pure 24 Pathogen 200 and/or Pathogen 1000 protocols to extract nucleic acids for an assay for a chronic infectious disease (e.g., Hepatitis C Virus), then suspected false positives should be evaluated further following local procedures and retested as necessary. " Complete the attached fax form and fax it to 1-844-861-6232 or email it to roche6612@stericycle.com. " File this Urgent Medical Device Correction (UMDC) for future reference.
• Quantity in Commerce: 163 units
• 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, South Africa, South Korea, Spain, Switzerland, Taiwan, UAE, United Kingdom, Vietnam.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.