FDA Medical Device Recalls (openFDA)
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.
- Recall number
- Z-1255-2009
- Recalling firm
- Roche Diagnostics Corp.
- 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.
- Status
- Terminated
- Initiated
- 2009-02-09
- Posted
- 2009-05-18
- Terminated
- 2009-12-07
- 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.
- Lot, serial or model codes
- All units.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- LXG
- Firm FEI
- 1823260
- Firm city
- Indianapolis
- Firm state
- IN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28