Recall Z-0490-2013 ยท NSX
Roche Molecular Systems, Inc.
The COBAS INTEGRA 400/400 plus system (software version 3.4) is a fully automated, computerized chemistry analyzer. It is intended for in vitro quantitative or qualitative determination of a wide range of analytes in various body fluids.
| Date | Dec 7, 2012 (initiated Jul 16, 2012) |
| Status | Terminated |
| 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 | 855 units. |
| Distribution | Nationwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.