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U.S. Department of Health and Human Services

Class 2 Device Recall Roche MagNA Pure LC Workstation

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  Class 2 Device Recall Roche MagNA Pure LC Workstation see related information
Date Initiated by Firm February 09, 2009
Date Posted May 18, 2009
Recall Status1 Terminated 3 on December 07, 2009
Recall Number Z-1255-2009
Recall Event ID 51071
Product Classification Equipment, laboratory, general purpose, labeled or promoted for a specific medical use - Product Code LXG
Product 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.
Code Information All units.
Recalling Firm/
Manufacturer		 Roche Diagnostics Corp.
9115 Hague Rd
Indianapolis IN 46256-1025
For Additional Information Contact
800-526-1247
Manufacturer Reason
for Recall		 Protruding screw threads may cut the user when cleaning the interior of the instrument.
FDA Determined
Cause 2		 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 in Commerce 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.
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.
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