Company: Siemens Healthcare Diagnostics, Inc.
Date of Enforcement Report 4/13/2016
Class lI:
PRODUCT
ADVIA 560 Hematology Systems, Siemens Material Number (SMN) 11170842, IVD The ADVIA 560 Hematology System is a fully-automated, high-quality hematology system for in vitro diagnostic use in clinical laboratories
Recall Number Z-1500-2016
REASON
TSoftware anomaly; Siemens identified that software version 1.4.2133 on the ADVIA 560 Hematology System does not trigger the following flags: The G or L morphology flags for immature granulocytes (IG) and atypical lymphocytes (ATYP), respectively. The results from patient samples which have immature granulocytes or atypical lymphocytes will not generate the flags when they should..
RECALLING FIRM/MANUFACTURER
Siemens Healthcare Diagnostics, Inc., Tarrytown, NY on 3/10/2016. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
US: 8 systems; Foreign: 64 systems
DISTRIBUTION
Nationwide and Internationally
___________________________________
