Recall Z-0536-2014 ยท JJH Clinical Sample Concentrator
Roche Diagnostics Operations, Inc.
MagNA Pure 96 System Version 1.0 Software Version 2.0 Robotic workstation for automated isolation of nucleic acids from different kinds of crude sample material (whole blood, serum, blood cells, culture cells, tissue, bacteria, fungi) by the use of the specially designed MagNA Pure reagent kits, automated filling of different kinds of PCR reaction vessels.
| Date | Dec 18, 2013 (initiated Nov 25, 13) |
| Status | Terminated |
| Reason | This issue is only relevant for customers importing xml files into the MagNA Pure 96 IVD instrument software for sample identification. There is a potential for sample mismatch when using the MagNA Pure 96 IVD instrument (catalog number 06541089001). Importing an order file in xml format to the MagNA Pure 96 IVD instrument software may result in a wrong sequence of samples in the graphical overvi |
| Root cause | Software design |
| Action | Roche Diagnostics sent an URGENT Medical Device Correction Notice dated November 25, 2013, to all affected customers. The letter identifies the product, problem, and actions to be taken by the customers. Customers were advised to discontinue use of the Pipetting Report and to use the sample list file instead. The MagNA Pure 96 Instrument Operators Guide is being updated with an addendum addressing this issue. The letter included a Customer Response Form for customers to complete and return to the firm by FAX : 1-888-670-4135. Please contact the Roche Support Network Customer Support Center |
| Quantity | 27 |
| Distribution | US Distribution including the states of AL, AZ, CA, CT, GA, NY, NC, NJ, OH, TX, VA and WA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.