Siemens Healthcare recalls Dimension Vista 500 software versions 3.7 and 3.8.1 due to potential aliquot well contamination if tests are cancelled during sample processing.
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 500 devices with specific software versions because canceling tests during sample aliquotting may cause contamination. This could lead to inaccurate test results if future samples are affected by contaminated wells.
If an operator cancels a test during sample aliquotting, the instrument may continue delivering the cancelled sample to the aliquot well. This can contaminate future samples or cause overflow, leading to inaccurate test results.
Users of Dimension Vista 500 devices with software versions 3.7 or 3.8.1 are affected. Laboratory technicians and medical staff who run these devices are most at risk of inaccurate test results.
Check for Dimension Vista 500 devices with software versions 3.7 or 3.8.1. The product is an in vitro diagnostic device used for lab testing.
Check if your device has software versions 3.7 or 3.8.1 and update to a newer version if available.
Siemens Healthcare identified an issue with Dimension Vista software versions 3.7 and 3.8.1 that may cause aliquot well contamination if tests are cancelled during sample processing.
Check for Dimension Vista 500 devices with software versions 3.7 or 3.8.1. The product is an in vitro diagnostic device used for lab testing.
Update to a newer software version if available. Siemens Healthcare does not provide a specific remedy for this issue in the recall notice.
We’ve drafted a message you can send Siemens Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-0616-2019 — Siemens Healthcare Siemens Healthcare Hello, I own a Siemens Healthcare that is covered by recall Z-0616-2019 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.
