Siemens Healthcare recalls Dimension Vista 1500 software versions 3.7 and 3.8.1 due to potential sample contamination if tests are cancelled during aliquotting. Affected units may require software update to prevent cross-contamination.
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.
Siemens Healthcare is recalling Dimension Vista 1500 lab equipment with specific software versions because canceling tests during sample processing could contaminate future samples. This affects labs using the device for medical testing and requires software updates to fix the issue.
The software may continue processing a canceled test sample after an operator stops the process, leading to cross-contamination of future samples. This happens only when tests are manually canceled during the sample aliquotting phase for calibration, QC, or patient samples.
Lab technicians and medical facilities using Siemens Dimension Vista 1500 with software versions 3.7 or 3.8.1 are most at risk. The issue primarily impacts labs handling patient samples during calibration or quality control checks.
Check if your Dimension Vista 1500 device has software version 3.7 or 3.8.1. The product is an in vitro diagnostic device used for medical testing procedures.
Install the latest software version from Siemens Healthcare to prevent sample contamination.
Siemens Healthcare identified a software issue in versions 3.7 and 3.8.1 that may cause sample contamination if tests are canceled during aliquotting.
Check if your Dimension Vista 1500 has software versions 3.7 or 3.8.1, as these specific versions are affected.
No, but updating the software will fix the issue. The recall does not require immediate discontinuation of use.
We’ve drafted a message you can send Siemens Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-0617-2019 — Siemens Healthcare Siemens Healthcare Hello, I own a Siemens Healthcare that is covered by recall Z-0617-2019 from Siemens Healthcare. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.