FDA Medical Device Recalls (openFDA)
Roche Molecular Systems, Inc.: The MagNA Pure LC (version 3.0) is a sample preparation instrument that can be used with the LightCycler instrument for automated isolation of nucleic acids in various types of biological materials.
- Recall number
- Z-0485-2013
- Recalling firm
- Roche Molecular Systems, Inc.
- Product
- The MagNA Pure LC (version 3.0) is a sample preparation instrument that can be used with the LightCycler instrument for automated isolation of nucleic acids in various types of biological materials.
- Status
- Terminated
- Initiated
- 2012-07-16
- Posted
- 2012-12-07
- Terminated
- 2015-07-22
- Reason
- Roche Molecular Systems, Inc. has become aware of a device-associated diagnostic software issue.
- Root cause
- Software design
- Action
- Roche sent an "Urgent Medical Device Correction" (UMDC) notification letter dated July 16, 2012, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Roche Molecular Systems, Inc. has disabled this software on affected Roche platforms and discontinued the distribution of the affected software. Contact Roche Diagnostic Technical Support, 24 hours a day, seven days a week at phone number : 1-800-428-2336 if you have questions regarding this notification. For questions regarding this recall call 908-253-7569.
- Quantity
- 816 units
- Distribution
- Nationwide Distribution
- Lot, serial or model codes
- Device-associated diagnostic software
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- NSX
- Firm FEI
- 2243471
- Firm city
- S Branchburg
- Firm state
- NJ
- 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
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
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