Dimension Vista 500, model no. 10284473 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.
Published December 26, 2018 · Recall initiated: October 16, 2018
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Siemens Healthcare Diagnostics has identified an issue with Dimension Vista software v.3.7 and v.3.8.1 that may result in aliquot well contamination. If a test is cancelled by the operator while the instrument is aliquotting the sample, the Dimension Vista instrument may continue to deliver the cancelled sample or vial contents to the aliquot well(s). Future samples may be assigned to the same aliquot well(s) and become contaminated with the existing contents or overflow of the aliquot well may occur potentially contaminating a surrounding well(s). This issue only occurs when an operator manually cancels a test(s) for calibration, quality control (QC) or patient sample while the instrument is in the process of aliquotting the sample.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Siemens Healthcare Diagnostics, Inc.
- Distributor
- Nationwide/worldwide distribution.
- Lot
- Dimension Vista software versions 3.7 and 3.8.1
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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