Company: Siemens Healthcare Diagnostics
Date of Enforcement Report: 10/7/2014
Class lI:
PRODUCT
ADVIA Centaur Immunoassay System (including refurbished units), This system is intended for professional use in a laboratory environment only. Tests performed using this system are intended for in vitro diagnostic use. As with all diagnostic tests, a definitive clinical diagnosis should not be based on the results of a single test, but should only be made by the physician after all clinical and laboratory findings have been evaluated.
Recall Number Z-2715-20144
REASON
The firm has identified an issue with patient demographic information sent to the LIS from the ADVIA Centaur/ADVIA Centaur XP Immunoassay systems. Siemens has confirmed that under extremely rare circumstances patient demographic data from the previous order received from the LIS is merged with the next order. This issue can occur when the LIS data buffer on the ADVIA Centaur system becomes full and a particular character is found in the last five locations in the LIS data buffer. In this case, the incorrect patient demographic information will be transmitted to the LIS and will be displayed on the ADVIA Centaur user interface and instrument generated printed reports.
RECALLING FIRM/MANUFACTURER
Siemens Healthcare Diagnostics, Tarrytown, NY on 8/19/2014 Voluntary: Firm Initiated recall is ongoing
VOLUME OF PRODUCT IN COMMERCE
Domestic: 2771 units; Foreign: 7744 unit
DISTRIBUTION
Nationwide and Internationally
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