—#78385

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.

FDA product code: LXG — Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use
Device class: Class 1
Medical specialty: Clinical Chemistry
Affected lot / code info: All units.

Why it was recalled

Protruding screw threads may cut the user when cleaning the interior of the instrument.

Root cause (FDA determination)

Device Design

Action the firm took

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.

Recalling firm

Firm: Roche Diagnostics Corp.
Address: 9115 Hague Rd, Indianapolis, Indiana 46256-1025

Distribution

Distribution pattern: 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.

Timeline

Recall initiated: 2009-02-09
Posted by FDA: 2009-05-18
Terminated: 2009-12-07
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #78385. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.