Recall Z-0484-2013
Roche Molecular Systems, Inc. · initiated July 16, 2012
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Data Station AMPLILINK software is an instrument user interface/ data management software used with COBAS AmpliPrep instrument, COBAS TaqMan analyzer, COBAS TaqMan 48 analyzer, COBAS AMPLICOR analyzer, and Cobas p 630 instrument for sample preparation, amplification and detection of PCR (Polymerase Chain Reaction) molecular diagnostic analytes.
Codes / lots: Device-associated diagnostic software
Reason for recall
Roche Molecular Systems, Inc. has become aware of a device-associated diagnostic software issue.
FDA-determined 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.
Details
- Recall number
- Z-0484-2013
- Initiated
- July 16, 2012
- Posted by FDA
- December 7, 2012
- Terminated
- July 22, 2015
- Quantity
- 884 units
- Distribution
- Nationwide Distribution
- Recalling firm
- Roche Molecular Systems, Inc., S Branchburg, NJ
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0485-2013 Class II | The MagNA Pure LC (version 3.0) is a sample preparation instrument that can be used with…Roche Molecular Systems, Inc. has become aware of a device-associated diagnostic software issue. | 07/16/2012Terminated |
| Z-0486-2013 Class II | The MagNA Pure 96 System (versions 1.0 and 2.0) is a sample preparation instrument for…Roche Molecular Systems, Inc. has become aware of a device-associated diagnostic software issue. | 07/16/2012Terminated |
| Z-0487-2013 Class II | LightCycler 1.2 (software version 3.5) is a Rapid PCR analyzer with real-time detection…Roche Molecular Systems, Inc. has become aware of a device-associated diagnostic software issue. | 07/16/2012Terminated |
| Z-0488-2013 Class II | LightCycler 2.0 Instrument (software version 4.1) is a Rapid PCR analyzer with real-time…Roche Molecular Systems, Inc. has become aware of a device-associated diagnostic software issue. | 07/16/2012Terminated |
| Z-0489-2013 Class II | The COBAS 8000 data manager modular analyzer series (all versions) is a is a fully…Roche Molecular Systems, Inc. has become aware of a device-associated diagnostic software issue. | 07/16/2012Terminated |
| Z-0490-2013 Class II | The COBAS INTEGRA 400/400 plus system (software version 3.4) is a fully automated…Roche Molecular Systems, Inc. has become aware of a device-associated diagnostic software issue. | 07/16/2012Terminated |
| Z-0491-2013 Class II | DataInnovations (Instrument Manager) (version 8.04) interfaces middleware between larger…Roche Molecular Systems, Inc. has become aware of a device-associated diagnostic software issue. | 07/16/2012Terminated |
| Z-0492-2013 Class II | DataCara GM is an information management system that provides data management…Roche Molecular Systems, Inc. has become aware of a device-associated diagnostic software issue. | 07/16/2012Terminated |
| Z-0493-2013 Class II | DataCare POC is an information management system that provides data management…Roche Molecular Systems, Inc. has become aware of a device-associated diagnostic software issue. | 07/16/2012Terminated |