Company:Siemens Healthcare Diagnostics, Inc.
Date of Enforcement Report 5/30/12
Class ll:

PRODUCT
Siemens Healthcare Diagnotics Dimension Vista(R) software version 3.4 The Dimension Vista(R) System is an in vitro diagnostic device intended to duplicate manual analytical procedures such as pipetting, mixing, heating, and measuring spectral intensities to determine a variety of analytes in human body fluids. Dimension Vista(R) chemical and immunochemical applications use photometric, turbidimetric, chemiluminescence, nephelometric and integrated ion-selective multisensory technology for clinical use. Recall # Z-1454-2012

REASON
Siemens has confirmed customer complaints on Vista(R) software version 3.4 for Below Manufacturer Assay Range error flags associated with QC and patient test results that are within the assay range as defined in the Instructions For Use for the respective method. This issue is isolated to Vista(R) software version 3.4. Customers who have not made any changes to the default method configurations are not affected. Other versions of Vista(R) are also not affected.

RECALLING FIRM/MANUFACTURER
Siemens Healthcare Diagnostics, Inc., Newark. DE, by letter dated December 19, 2011 and on January 16, 2012. Firm initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
1683 units

DISTRIBUTION
Nationwide and Internationally

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