Company: Siemens Healthcare Diagnostics, Inc..
Date of Enforcement Report: 2/5/2014
Class lI:
PRODUCT
Siemens CentraLink” Data Management System V14.0.4, V14.0.5 or V14.0.8_x000D_ _x000D_ 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.
Recall Number Z-0823-2014
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.)
RECALLING FIRM/MANUFACTURER
Siemens Healthcare Diagnostics, Inc., Newark, DE on 10/30/2013. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
40
DISTRIBUTION
US Distribution in the states of: MN, NJ, and NV.
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