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U.S. Department of Health and Human Services

Enforcement Report - Week of September 4, 2013

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Product Detail

Product Description 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
Classification Class II
Code Info Dimension Vista 500 Siemens material numbers: 10284473 (domestic), and 10488224 (international), Dimension Vista 1500 Siemens material numbers: 10444801 (domestic) and 10444802 (international).
Product Distributed Qty 1937
Reason For Recall 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.

Event Detail

Event Id 65607
Product Type Devices
Status Ongoing
Recalling Firm Siemens Healthcare Diagnostics, Inc.
City Newark
State DE
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-06-19
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern Worldwide distribution: US (nationwide) including PR and countries of: Australia, Austria, Belgium, Canada, Czech Republic, Denmark, Finland, France, Germany, Italy, Japan, Malaysia, Netherlands, New Zealand, Norway, Portugal, Republic Korea, Saudia Arabia, Slovakia, Slovenia, South Africa, Spain, Switzerland, and United Kingdom.
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