Device product
Siemens CentraLink" Data Management System V14.0.4, V14.0.5 or V14.0.8 The CentraLink system software is a network solution provider and multi-system data manager for the instruments and lab automation systems (LAS) within the lab. The CentraLink software consolidates data from all connected instruments so that an operator can review and edit patient and quality control results from a single location.
Z-0823-2014
Product summary
- Event
- Event 66694
- Status
- Terminated
- Classification
- Class II
- Quantity
- 40
- Official record key
device-enforcement:Z-0823-2014
Official wording
Reason: Under extremely rare circumstances, a patient result that had been previously disabled may be released without proper review. (Disabled Test in CentraLink System or Aptio System May Become Enabled in CentraLink System.)
Code information: CentraLink" Data Management System V14.0.4, V14.0.5 or V14.0.8 Catalog Numbers: 10810210, 10811596, 10814296, 10814298, 10814877, 10815474.
Distribution pattern: US Distribution in the states of: MN, NJ, and NV.
Derived failure modes
-
Unknown
Under extremely rare circumstances, a patient result that had been previously disabled may be released without proper review. (Disabled Test in CentraLink System or Aptio System May Become Enabled in CentraLink System.)