Company: Siemens Healthcare Diagnostics, Inc.
Date of Enforcement Report 12/14/2016
Class lI:
PRODUCT
ADVIA 560 Hematology Systems, Siemens Material Number (SMN) 11170842, IVD.
Recall Number Z-0723-2017
REASON
Siemens is investigating an issue which may cause an incorrect result to be reported. Siemens received two reports of multiple discordant records for the same Sample ID in the ADVIA 560 Hematology System database that occurred during the installation of the systems. The database should only contain one record of a Sample ID number for any given time and date. If there are multiple records for the same Sample ID, it is possible that multiple results may be manually or automatically sent to the Laboratory Information System (LIS), printed or displayed on the results report screen.
RECALLING FIRM/MANUFACTURER
Siemens Healthcare Diagnostics, Inc., Tarrytown, NY on 10/21/2016 Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
US: 23 systems; Foreign: 141 systems
DISTRIBUTION
Nationwide and Internationally
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