Recall Z-0616-2019 ยท JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Siemens Healthcare Diagnostics, Inc.
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.
| Date | Oct 16, 2018 |
| Status | Terminated |
| 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 manua |
| Root cause | Under Investigation by firm |
| Action | 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 p |
| Quantity | 1649 |
| Distribution | Nationwide/worldwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K051087 | DIMENSION VISTA INTEGRATED SYSTEM Dade Behring, Inc., Jul 11, 2005 |