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Lower risk Medical device recall · FDA · Published October 15, 2021

Siemens Dimension Vista 50: Incorrect HIL Index May Affect Test Results

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.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-0331-2022Medical deviceSiemens Healthcare ›
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Contact the company

Recalling firmSiemens Healthcare Diagnostics, Inc.500 Gbc Dr · Newark, DE 19702-2466
✎ GovInfoNow plain-language explainer

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. Read more at govinfonow.com/recall/61668-siemens-dimension-vista-50-incorrect-hil-index-may-affect-test.

Source Summary by GovInfoNow · govinfonow.com/recall/61668-siemens-dimension-vista-50-incorrect-hil-index-may-affect-test · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0331-2022

Cite this page

“Siemens Dimension Vista 50: Incorrect HIL Index May Affect Test Results.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/61668-siemens-dimension-vista-50-incorrect-hil-index-may-affect-test. Based on FDA recall #Z-0331-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0331-2022%22&limit=1).

The FDA announced on 2021-10-15 that Siemens Healthcare Diagnostics, Inc. is recalling Dimension Vista 500- in-vitro diagnostic devices due to incorrect default hemolysis, icterus or lipemia index values for five assays. The agency said the recall addresses a Class II hazard involving potential inaccurate test results.

How to tell if you have it

  • Brand: Siemens Healthcare
  • Product: Dimension Vista 500- In-vitro diagnostic device intended to duplicate manual analytical procedures such as pipetting
  • UPC: 00630414949581
  • UPC: 00630414989556

The hazard

The recall addresses incorrect default hemolysis, icterus or lipemia (HIL) index values for five Dimension Vista assays. The device is intended to duplicate manual analytical procedures such as pipetting, mixing, heating, and measuring spectral intensities to determine analytes in human body fluid.

Context

GovInfoNow's records show Siemens Healthcare Diagnostics, Inc. has 150 other recalls on record since 2017-06-07. Other recent recalls of similar products include Siemens Atellica CH RCRP Test May Give False High Results (2026-08-17), Beckman Coulter Emit 2000 Quinidine Assay Recall: Risk of Incorrect Patient Treatment (2026-07-13), and Siemens Atellica CH Urine Albumin Recall: False Results Risk (2026-07-06). Other recent recalls of similar products include PIE Medical Imaging 3mensio Workstation Software Recall: Measurement Errors in Vascular Imaging (2026-05-07), Diagnostica Stago Asserachrom HPIA Kit Recall: False Negative Results Risk (2025-12-15), and Siemens Healthineers Immulite 2000 Syphilis Screen Recall: False Negative Risk (2026-07-13).

How to tell if you have this one

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.

  • Brand
    Siemens Healthcare
  • Product
    Dimension Vista 500- In-vitro diagnostic device intended to duplicate manual analytical procedures such as pipetting
  • Category
    Medical device
FDA recall event · 2 products

All 2 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

  • Classification
    Class II
  • Status
    Terminated
  • Distribution
    Worldwide distribution - US Nationwide distribution and the countries of DE, ES, FR, IT, CA, NL, JP, PT, AU, CZ, AT, DK, SI, BE, SK, QA, SA, KR, CH.
Recall numberProduct, codes & lotsQuantity
Z-0330-2022Dimension Vista 1500 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 fluid SMN: 10444801(US) and 10444802 (OUS); All software versions prior to 3.10.2. GTIN: 00630414949741 and 00630414945460 (GTIN + Instrument Serial Number = Unique Device Identification (UDI)1407 units
Z-0331-2022Dimension Vista 500- 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 fluid SMN: 10284473 (US) and 10488224 (OUS); All software versions prior to 3.10.2. GTIN: 00630414949581 and 00630414989556 (GTIN + Instrument Serial Number = Unique Device Identification (UDI)1326 units
Based on the official FDA remedy

What to do — step by step

  1. Check Software Version

    Verify the software version on your device; affected units have versions prior to 3.10.2.

Where it went and when

Where it was distributed

Distributed nationwide, and outside the U.S.

Alaska: yesAKMaine: yesMEVermont: yesVTNew Hampshire: yesNHWashington: yesWAIdaho: yesIDMontana: yesMTNorth Dakota: yesNDMinnesota: yesMNIllinois: yesILWisconsin: yesWIMichigan: yesMINew York: yesNYRhode Island: yesRIMassachusetts: yesMAOregon: yesORNevada: yesNVWyoming: yesWYSouth Dakota: yesSDIowa: yesIAIndiana: yesINOhio: yesOHPennsylvania: yesPANew Jersey: yesNJConnecticut: yesCTCalifornia: yesCAUtah: yesUTColorado: yesCONebraska: yesNEMissouri: yesMOKentucky: yesKYWest Virginia: yesWVVirginia: yesVAMaryland: yesMDDelaware: yesDEArizona: yesAZNew Mexico: yesNMKansas: yesKSArkansas: yesARTennessee: yesTNNorth Carolina: yesNCSouth Carolina: yesSCDistrict of Columbia: yesDCOklahoma: yesOKLouisiana: yesLAMississippi: yesMSAlabama: yesALGeorgia: yesGAHawaii: yesHITexas: yesTXFlorida: yesFL

FDA distribution: “Worldwide distribution - US Nationwide distribution and the countries of DE, ES, FR, IT, CA, NL, JP, PT, AU, CZ, AT, DK, SI, BE, SK, QA, SA, KR, CH.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide, and outside the U.S.

Recall timeline

FDA terminated this recall 2.6 years after the firm started it.

1. Firm started the recall: Oct 15, 202112. FDA classified it Class II: Dec 2, 202123. Published in FDA’s Enforcement Report: Dec 8, 202134. FDA terminated the recall: May 13, 2024420212024
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report
  4. FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

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Where this comes from

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.

  • Official source: FDA Recall #Z-0331-2022 (October 15, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0331-2022 to see it in context.
  • Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
  • GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA