Company:Siemens Healthcare Diagnostics, Inc.
Date of Enforcement Report 4/18/12
Class ll:
PRODUCT
EasyLink(TM) Informatics Systems Software Version 5.0 and Software Version 5.0 Service Packs 1 through 4 used with the Dimension Vista(R) System. The EasyLink(TM) Informatics System is classified as a data calculator and processing module for use with In-vitro diagnostics devices. The EasyLink(TM) is included with the Dimension Vista(R) System, and may be used with other Siemens analyzers, as a communications and connectivity workstation for integration with laboratory information system (LIS) networks. Catalog number 1000034805. Recall # Z-1391-2012
REASON
QC results may be unexpectedly associated with a Pending Control. When this situation occurs, Pending QC Controls maybe be created or reused.
RECALLING FIRM/MANUFACTURER
Siemens Healthcare Diagnostics, Inc., Newark, DE, by letter dated December 2011. Firm initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
787
DISTRIBUTION
Nationwide and Internationally
