Recall Z-1956-2018 · JJH Clinical Sample Concentrator

Roche Molecular Systems, Inc.

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 managemen

Date	May 2, 2018
Status	Terminated
Reason	Cross-contamination of samples has been reported when running the existing protocol on the system with the rack-based purification run.
Root 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	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
FDA record	Open on fda.gov

510(k) clearances named in this recall

This recall record lists no 510(k) number.