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.
- Company
- Roche Molecular Systems, Inc.
- Recall Initiated
- July 16, 2012
- Posted
- December 7, 2012
- Terminated
- July 22, 2015
- Recall Number
- Z-0490-2013
- Quantity
- 855 units.
- Firm Location
- Branchburg, NJ
Reason for Recall
Roche Molecular Systems, Inc. has become aware of a device-associated diagnostic software issue.
Distribution
Nationwide Distribution
Lot / Code Info
Device-associated diagnostic software
Root Cause
Software design
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.