Company: Siemens Healthcare Diagnostics, Inc..
Date of Enforcement Report: 12/11/2013
Class lI:
PRODUCT
Dimension Vista(R) 500 and Dimension Vista(R) 1500 – Reloaded Vista Vials – limited to systems using software versions 3.4 and 3.5.1. Diagnostic device intended to determine a variety of analytes in human body fluids. Recall Number Z-0430-2014
REASON
There is the potential for the vial volume of “in use” Vista calibrators, controls, or sample diluent to incorrectly revert to full volume when removed and reloaded. Dimension Vista(R) 500 and Dimension Vista(R) 1500 – Reloaded Vista Vials – limited to systems using software versions 3.4 and 3.5.1.
RECALLING FIRM/MANUFACTURER
Siemens Healthcare Diagnostics, Inc., Newark, DE on 5/20/2013. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
776
DISTRIBUTION
Nationwide and Canada
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