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.
This recall has been terminated (originally issued May 18, 2009).
- Company
- Roche Diagnostics Corp.
- Recall Initiated
- February 9, 2009
- Posted
- May 18, 2009
- Terminated
- December 7, 2009
- Recall Number
- Z-1255-2009
- Quantity
- 371
- Firm Location
- Indianapolis, IN
- Official Source
- View on FDA website ↗
Reason for Recall
Protruding screw threads may cut the user when cleaning the interior of the instrument.
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.
Lot / Code Info
All units.
Root Cause
Device Design
Action Taken
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.