FDA-Device2014-01-29Class II
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.
Siemens Healthcare Diagnostics, Inc.
Hazard
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.)
Sold states
US Distribution in the states of: MN, NJ, and NV.
Affected count
40
Manufactured in
500 Gbc Dr Ms 514, PO BOX 6101, Newark, DE, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0823-2014Don't want to check this manually?
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