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Lower risk Medical device recall · FDA · Published February 3, 2021

Siemens Dimension Vista HDLC Reagent May Give Erroneous Results

Siemens Healthcare recalls Dimension Vista HDLC reagent lot 20062BA due to potential for discoloration in wells 5 and 6 causing inaccurate lipid test results.

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

🇺🇸 FDA recall #Z-1188-2021Medical 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 HDLC reagent cartridges with lot number 2006:2BA because discolored wells 5 and 6 may cause inaccurate lipid test results. This affects lab tests for diabetes, liver disease, and heart health. Users should check their reagent lot numbers and contact Siemens if they have this specific batch. Read more at govinfonow.com/recall/63315-siemens-dimension-vista-hdlc-reagent-may-give-erroneous-results.

Source Summary by GovInfoNow · govinfonow.com/recall/63315-siemens-dimension-vista-hdlc-reagent-may-give-erroneous-results · Updated August 19, 2026 · FDA enforcement record: FDA #Z-1188-2021

Cite this page

“Siemens Dimension Vista HDLC Reagent May Give Erroneous Results.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/63315-siemens-dimension-vista-hdlc-reagent-may-give-erroneous-results. Based on FDA recall #Z-1188-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1188-2021%22&limit=1).

The FDA announced on Feb. 3, 2021, that Siemens Healthcare Diagnostics Inc. is recalling Dimension Vista HDLC reagent cartridges due to the potential for erroneous results from discolored reagent. The agency issued recall number Z-1188-2021 for the Class II voluntary recall.

How to tell if you have it

  • Brand: Siemens Healthcare
  • Product: Dimension Vista HDLC - colorimetric method, lipoproteins (DV HDLC)
  • Lot code: 20062BA
  • UDI Number: 0084276802043820062BA21030210464340840

The hazard

Siemens Healthcare Diagnostics Inc. confirmed the potential for erroneous results due to discolored reagent observed in some wells 5 and 6 of Dimension Vista High Density Lipoprotein Cholesterol (HDLC) Flex reagent cartridges lot 20062BA.

Context

GovInfoNow's records show Siemens Healthcare Diagnostics, Inc. has had 150 other recalls on record since June 7, 2017. Other recent recalls of similar products include Siemens Atellica CH RCRP Test May Give False High Results (Aug. 17, 2026), Siemens Healthcare Syva EMIT 2000 Quinidine Assay Recall: Risk of Inaccurate Test Results (July 13, 2026), and Siemens Atellica CH Urine Albumin Recall: False Results Risk (July 6, 2026). Other recent recalls of similar products include HardyDisk AST Cefiderocol 30μg FDC30: False Susceptibility Results Risk (June 8, 2026), Abbott i-STAT EG6+ Cartridges May Show Wrong Blood Gas Results (April 1, 2026), and Beckman Coulter LDL Cholesterol Reagent May Give False High Results (Dec. 8, 2025).

How to tell if you have this one

Check for the lot number 20062BA on the reagent cartridge. The product is used for lipid tests and is sold by Siemens Healthcare Diagnostics.

  • Brand
    Siemens Healthcare
  • Category
    Medical device
Based on the official FDA remedy

What to do — step by step

  1. Check Reagent Lot Number

    Look for the lot number 20062BA on the Dimension Vista HDLC reagent cartridge.

Where it went and when

Where it was distributed

Distributed nationwide and abroad; the notice names 44 states.

Alaska: named in the noticeAKMaine: named in the noticeMEVermont: nationwideVTNew Hampshire: named in the noticeNHWashington: named in the noticeWAIdaho: named in the noticeIDMontana: named in the noticeMTNorth Dakota: nationwideNDMinnesota: named in the noticeMNIllinois: named in the noticeILWisconsin: named in the noticeWIMichigan: named in the noticeMINew York: named in the noticeNYRhode Island: nationwideRIMassachusetts: named in the noticeMAOregon: named in the noticeORNevada: named in the noticeNVWyoming: named in the noticeWYSouth Dakota: nationwideSDIowa: named in the noticeIAIndiana: named in the noticeINOhio: named in the noticeOHPennsylvania: named in the noticePANew Jersey: named in the noticeNJConnecticut: named in the noticeCTCalifornia: named in the noticeCAUtah: named in the noticeUTColorado: named in the noticeCONebraska: named in the noticeNEMissouri: named in the noticeMOKentucky: named in the noticeKYWest Virginia: named in the noticeWVVirginia: named in the noticeVAMaryland: named in the noticeMDDelaware: named in the noticeDEArizona: named in the noticeAZNew Mexico: named in the noticeNMKansas: named in the noticeKSArkansas: named in the noticeARTennessee: named in the noticeTNNorth Carolina: named in the noticeNCSouth Carolina: named in the noticeSCDistrict of Columbia: named in the noticeDCOklahoma: nationwideOKLouisiana: named in the noticeLAMississippi: named in the noticeMSAlabama: named in the noticeALGeorgia: named in the noticeGAHawaii: nationwideHITexas: named in the noticeTXFlorida: named in the noticeFLPuerto Rico: named in the noticePR

FDA distribution: “Worldwide distribution - US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OR, PA, PR, SC, TN, TX,…” States read from FDA’s own wording; “not listed” means the notice does not name it.

Named in the notice: Alabama, Alaska, Arizona, Arkansas, California, Colorado, Connecticut, Delaware, District of Columbia, Florida, Georgia, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Montana, Nebraska, Nevada, New Hampshire, New Jersey, New Mexico, New York, North Carolina, Ohio, Oregon, Pennsylvania, Puerto Rico, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, West Virginia, Wisconsin, Wyoming.

Recall timeline

FDA published this recall 42 days after the firm started it.

1. Firm started the recall: Feb 3, 202112. FDA classified it Class II: Mar 8, 202123. Published in FDA’s Enforcement Report: Mar 17, 202132021
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report

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-1188-2021 (February 3, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1188-2021 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