—#168816

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.

FDA product code: JJE — Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Device class: Class 1
Medical specialty: Clinical Chemistry
510(k) numbers: K051087
Affected lot / code info: Dimension Vista software versions 3.7 and 3.8.1

Why it was 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 manually cancels a test(s) for calibration, quality control (QC) or patient sample while the instrument is in the process of aliquotting the sample.

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

On October 16, 2018, the firm notified customers via Urgent Medical Device Correction letters. The letters informed customers of the product issue. Actions to be Taken by the Customer 1. Whenever possible, order/test(s) for calibration, QC or patient samples should only be cancelled by the operator when the system has finished aliquotting the sample. " Once the Sample Rack has been unloaded from the Dimension Vista the test(s) may be cancelled following normal procedure. " For automation systems once the tube has been released back to the track the test(s) may be cancelled following normal procedure. 2. If the order/test(s) for calibration, QC or patient samples must be cancelled while the sample is onboard the system, please follow the instructions below: a. From the Operation menu select Pause. b. When System Paused displays in the status area, the test(s) may be cancelled. c. From the Operation menu select Reset to reset the Dimension Vista. 3. If order/test(s) for calibration, QC or patient samples were cancelled by the operator while the sample is onboard the system and the system was not paused: a. From the Operations menu select Stop. All in-progress tests will be aborted b. From the Operations menu select Shutdown c. The console menu is displayed. To restart system, select Start Vista. In addition, please perform the following: " Review this letter with your Medical Director. " Please retain this letter with your laboratory records, and forward this letter to those who may have received this product. " Return the completed Field Action Effectiveness Form to Siemens Healthcare Diagnostics as instructed in the last page of this letter. If you have any questions, please contact your Siemens Customer Care Center or your local Siemens Technical Support Representative.

Recalling firm

Firm: Siemens Healthcare Diagnostics, Inc.
Address: 500 Gbc Dr Ms 514, Newark, Delaware 19702-2466

Distribution

Distribution pattern: Nationwide/worldwide distribution.

Timeline

Recall initiated: 2018-10-16
Terminated: 2020-06-17
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #168816. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.