The Recall Desk

FDA (Devices) recall action 81478

Siemens Healthcare Diagnostics, Inc. recalled 2 products on 2018-12-26

The FDA (Devices) publishes a recall like this one as 2 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 2 pages.

Products
2
Announced
2018-12-26
Critical
0
Units
3,277

Why these products were recalled

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 man…

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

1–2 of 2

  • HighFDA (Devices)··2018-12-26

    Siemens Dimension Vista 1500 Recalled for Potential Sample Contamination

    Siemens is recalling Dimension Vista 1500 instruments due to a software issue that may cause sample contamination if tests are manually cancelled during aliquoting.

    Product
    Dimension Vista 1500, Model No. 10444801 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.
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2018-12-26

    Siemens Dimension Vista 500 Recalled for Sample Contamination Risk

    Siemens is recalling Dimension Vista 500 instruments due to a software issue that may cause sample contamination if tests are manually cancelled during aliquoting.

    Product
    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.
    Category
    Distribution
    0 states