Recall Z-1255-2009 ยท LXG Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use
Roche Diagnostics Corp.
Roche MagNA Pure LC Workstation; Product Numbers: 12236931001, 12236931444, 12236931692 and 03670325001. Robotic workstation for automated isolation of nucleic acids from different kinds of crude sample material such as whole blood, serum, blood cells, culture cells, tissue, bacteria and fungi.
| Date | May 18, 2009 (initiated Feb 9, 2009) |
| Status | Terminated |
| Reason | Protruding screw threads may cut the user when cleaning the interior of the instrument. |
| Root cause | Device Design |
| Action | In a letter titled "Urgent Medical Device Correction" dated February 9, 2009, consignees were notified of the protruding screws and instructed to use caution when cleaning the instrument until a protective plate is installed by the firm's field representative. Further questions should be addressed to Roche Molecular Diagnostics Technical Support at 1-800-526-1247. |
| Quantity | 371 |
| Distribution | Nationwide Distribution including Puerto Rico and states of AL, AR, AZ, CA, CO, CT, DE, FL, GA, HA, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NJ, NV, NY, OH, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI and WV. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.