Recall – IVD Software error leads to contamination

Company: Siemens Healthcare Diagnostics, Inc.
Date of Enforcement Report: 12/14/2018
Class II

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.

Recall Number: Z-0616-2019 (Vista 500, Model no:10284473)

Recall Number: Z-0617-2019 (Vista 1500, Model no:10444801)

REASON

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.

RECALLING FIRM/MANUFACTURER

Siemens Healthcare Diagnostics, Inc., Newark, DE on 10/16/2018. Voluntary: Firm Initiated, recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
1649 (Vista 500, Model no:10284473)

1628 (Vista 1500, Model no:10444801)

DISTRIBUTION
U.S. Nationwide and International

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