The MagNA Pure LC (version 3.0) is a sample preparation instrument that can be used with the LightCycler instrument for
FDA device recall Z-0485-2013 · posted 2012-12-07 · Terminated
Recall details
- Recalling firm
- Roche Molecular Systems, Inc.
- Reason for recall
- Roche Molecular Systems, Inc. has become aware of a device-associated diagnostic software issue.
- Action taken
- 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.
- Root cause
- Software design
- Status
- Terminated
- Product code
- NSX
- Quantity affected
- 816 units
- Distribution
- Nationwide Distribution
- Date initiated
- 2012-07-16
- Date posted
- 2012-12-07
- Date terminated
- 2015-07-22
- Location
- S Branchburg, NJ
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