Siemens Healthcare recalls Dimension Vista 500 diagnostic devices with incorrect HIL index settings that could lead to inaccurate test results. Affected units have specific serial numbers and software versions.
Incorrect Default Hemolysis, Icterus or Lipemia (HIL) Index for Five Dimension Vista Assays
Siemens Healthcare is recalling Dimension Vista 500 diagnostic devices because they may provide incorrect hemolysis, icterus, or lipemia index readings. This could lead to inaccurate test results if the device is used without proper calibration.
The device may display incorrect hemolysis, icterus, or lipemia index values for five specific assays. This can cause inaccurate test results if the device is used without proper calibration or maintenance.
Users of the Dimension Vista 500 diagnostic device for in-vitro testing are affected. Laboratory staff and healthcare professionals who rely on this device for accurate test results are most at risk.
Check for the serial number and software version on the device. Affected units have specific serial numbers and software versions prior to 3.10.2.
Verify the software version on your device; affected units have versions prior to 3.10.2.
The device may provide incorrect hemolysis, icterus, or lipemia index readings for five specific assays, which could lead to inaccurate test results.
Check the software version; affected units have versions prior to 3.10.2. Also, verify the serial number and GTIN as listed in the recall notice.
The recall does not specify a remedy, so contact Siemens Healthcare directly for guidance on next steps.
We’ve drafted a message you can send Siemens Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-0331-2022 — Siemens Healthcare Siemens Healthcare Hello, I own a Siemens Healthcare that is covered by recall Z-0331-2022 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.
