Siemens Healthcare recalls Dimension Vista 1500 diagnostic devices with incorrect HIL index settings that may cause inaccurate blood test results. Affected units have specific software versions and serial numbers.
Incorrect Default Hemolysis, Icterus or Lipemia (HIL) Index for Five Dimension Vista Assays
Siemens Healthcare is recalling Dimension Vista 1500 diagnostic devices that may give inaccurate blood test results due to incorrect HIL index settings. This could lead to wrong health conclusions from the tests.
The device uses a wrong HIL index setting for five specific blood tests, which can cause inaccurate results. This might lead to incorrect health conclusions if the tests are used for critical decisions.
People using the Dimension Vista 1500 for blood tests may be affected if their device has the incorrect software version. Lab technicians and healthcare providers are most at risk.
Check if your device has software version 3.10.2 or earlier. The serial number and GTIN codes are listed in the recall notice for identification.
Verify your device's software version; affected units have versions prior to 3.10.2.
The device has incorrect HIL index settings for five blood tests, which may cause inaccurate results.
No, but you should check your software version to see if it's affected.
Check if your software version is prior to 3.10.2 or if your device has the specific serial numbers listed 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-0330-2022 — Siemens Healthcare Siemens Healthcare Hello, I own a Siemens Healthcare that is covered by recall Z-0330-2022 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.