Roche MagNA Pure LC Workstation; Product Numbers: 12236931001, 12236931444, 12236931692 and 03670325001. Robotic worksta
FDA device recall Z-1255-2009 · posted 2009-05-18 · Terminated
Recall details
- Recalling firm
- Roche Diagnostics Corp.
- Reason for recall
- Protruding screw threads may cut the user when cleaning the interior of the instrument.
- 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.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- LXG
- Quantity affected
- 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,
- Date initiated
- 2009-02-09
- Date posted
- 2009-05-18
- Date terminated
- 2009-12-07
- Location
- Indianapolis, IN
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