Company:Siemens Healthcare Diagnostics, Inc.
Date of Enforcement Report: 9/4/2013
Class ll:
PRODUCT
Dimension Vista 500 and Dimension Vista 1500 System Aliquot Well Double Dispense with software versions 3.5.1 and 3.6. 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 chemical and immunochemical applications use photometric, turbidimetric, chemiluminescence, nephelometric, and integrated ion-selective multisensory technology for clinical use. Recall Number Z-2088-2013
REASON
Siemens is conducting a field correction for Dimension Vista 500 and Dimension Vista 1500 systems using software versions 3.5.1 and 3.6. Under specific rare conditions which require a system reset, there is a potential for a sample to be dispensed into an aliquot well that has previously been used for a QC or calibrator product from a Vista vial. If two samples are dispensed into the same aliquot well, the first sample will always be QC or calibrator from a Vista vial. Patient sample will never be dispensed into an aliquot well that contains another patient sample. The possible combinations are 1.) patient sample dispensed on QC or calibrator from a Vista vial, 2) QC from a Vista vial or any other sample container dispensed on QC or calibrator from a Vista vial, and 3) Calibrator from a Vista vial or any other sample container dispensed on QC or calibrator from a Vista vial.
RECALLING FIRM/MANUFACTURER
Siemens Healthcare Diagnostics, Inc., Newark, DE on 6/19/2013. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
1937
DISTRIBUTION
Nationwide and Internationally
___________________________________
