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Lower risk Medical device recall · FDA · Published January 28, 2022

Siemens Dimension Vista Magnesium Flex Reagent Cartridge Recall: Potential for Erroneous

Siemens recalls Magnesium Flex reagent cartridges (Material #10445158) that may cause QC failures or incorrect patient results. Affected lots include 21253BB, 21263BA, and 21335AA. Contact Siemens for remedy.

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

🇺🇸 FDA recall #Z-0830-2022Medical deviceSiemens ›
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Contact the company

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

Siemens is recalling Magnesium Flex reagent cartridges that may cause inaccurate test results or repeat testing. This could lead to incorrect diagnoses or treatments if the cartridges are used without proper quality control. Read more at govinfonow.com/recall/61208-siemens-dimension-vista-magnesium-flex-reagent-cartridge-recall-potential-for.

Source Summary by GovInfoNow · govinfonow.com/recall/61208-siemens-dimension-vista-magnesium-flex-reagent-cartridge-recall-potential-for · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0830-2022

Cite this page

“Siemens Dimension Vista Magnesium Flex Reagent Cartridge Recall: Potential for Erroneous.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/61208-siemens-dimension-vista-magnesium-flex-reagent-cartridge-recall-potential-for. Based on FDA recall #Z-0830-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0830-2022%22&limit=1).

The FDA announced on Jan. 28, 2022, that Siemens Healthcare Diagnostics, Inc. is recalling Dimension Vista Magnesium Flex reagent cartridges due to potential for erroneous patient results. The agency said the recall addresses imprecision and abnormal assay flags in specific lots.

How to tell if you have it

  • Brand: Siemens
  • Product: Dimension Vista Magnesium Flex reagent cartridge (MG)
  • Material #: 10445158
  • Catalog #: K3057
  • Lot codes: 21253BB, 21263BA, 21335AA
  • Distribution: Worldwide, including 47 U.S. states and Australia, Canada, Netherlands

The hazard

The FDA said the recalled lots exhibit imprecision and intermittent Abnormal Assay flags. This issue may lead to QC failures or erroneous patient results which may lead to repeat and follow-up testing.

Context

GovInfoNow's records show Siemens Healthcare Diagnostics, Inc. has 150 other recalls on record since 2026-08-17. 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 HardyDisk AST Cefiderocol 30μg FDC30: False Susceptibility Results Risk (2026-06-08), GEM Premier 5000 Cartridges May Cause Errors During Warm-Up - Recall (2026-01-20), and Fujirebio Lumipulse G pTau 217 Cartridges May Give False Alzheimer's Test Results (2025-12-11).

How to tell if you have this one

Check the lot number on the cartridge: 21253BB, 21263BA, or 21335AA. The product uses Material #10445158 and Catalog #K3057 in the Dimension Vista system.

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

What to do — step by step

  1. Check Cartridge Lot Number

    Look for lot numbers 21253BB, 21263BA, or 21335AA on the reagent cartridge.

Where it went and when

Where it was distributed

Distributed nationwide and abroad; the notice names 46 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: named in the noticeRIMassachusetts: 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: nationwideDCOklahoma: named in the noticeOKLouisiana: 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) 47 States including: AK, AL, AR, AZ, CA, CO, CT, 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, OK, OR, PA, PR, RI, SC, TN, TX, UT, VA, WA,…” 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, 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, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, West Virginia, Wisconsin, Wyoming.

Recall timeline

FDA published this recall 2 months after the firm started it.

1. Firm started the recall: Jan 28, 202212. FDA classified it Class II: Mar 28, 202223. Published in FDA’s Enforcement Report: Apr 6, 202232022
  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-0830-2022 (January 28, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0830-2022 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