Home / Recalls / Siemens Healthcare Diagnostics, Inc. / Z-0617-2019

Z-0617-2019 Class II Terminated

Recalled by Siemens Healthcare Diagnostics, Inc. — Newark, DE

FDA device recall Z-0617-2019 was initiated by Siemens Healthcare Diagnostics, Inc. on Oct 16, 2018 and is designated Class II. Reason for recall: 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… The recall status is terminated (terminated Jun 17, 2020). Affected quantity: 1628.

Recall Details

Product Type
Devices
Report Date
Dec 26, 2018
Initiation Date
Oct 16, 2018
Termination Date
Jun 17, 2020
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
1628

Product Description

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.

Reason for Recall

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.

Distribution Pattern

Nationwide/worldwide distribution.

Code Information

Dimension Vista software versions 3.7 and 3.8.1

Source

Dataset
openFDA device recall enforcement reports
FDA record
This recall in openFDA (JSON)
Enforcement Report
Search FDA's Enforcement Report for Z-0617-2019
openFDA file date
Oct 21, 2026
Loaded by RegDataLab
Oct 23, 2026

These dates say when openFDA published the data file and when RegDataLab last loaded it.

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FDA data resources