Lower risk Medical device recall · FDA · Published March 18, 2026

Siemens Dimension Creatinine Flex Reagent Cartridge Recall: Potential Creatinine

Siemens Healthcare recalls Dimension Creatinine Flex reagent cartridges with lot numbers GA6307 and BA7005 due to potential inaccuracies in creatinine patient results. Affected units may show erroneously low or high creatinine levels.

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

🇺🇸 FDA recall #Z-1980-2026Medical device Siemens Healthcare ›

Lower-risk recall

Siemens Healthcare Diagnostics is recalling certain lots of Dimension Creatinine Flex reagent cartridge (Dimension CRE2) because a potential imprecision in the Dimension CRE2 quality control (QC) and patient sample results using lot numbers GA6307 and BA7005 on the Dimension System. This imprecision may lead to erroneously decreased or increased creatinine patient results

Take action

Contact the company

Recalling firmSiemens Healthcare Diagnostics, Inc.500 Gbc Dr · Newark, DE 19702-2466

✎ GovInfoNow plain-language explainer

Siemens Healthcare is recalling certain Dimension Creatinine Flex reagent cartridges because they may cause inaccurate creatinine test results. This could lead to incorrect health assessments for patients using these cartridges. Read more at govinfonow.com/recall/49706-siemens-dimension-creatinine-flex-reagent-cartridge-recall-potential-creatinine-measurement.

Source Summary by GovInfoNow · govinfonow.com/recall/49706-siemens-dimension-creatinine-flex-reagent-cartridge-recall-potential-creatinine-measurement · Updated August 18, 2026 · FDA enforcement record: FDA #Z-1980-2026

Cite this page

“Siemens Dimension Creatinine Flex Reagent Cartridge Recall: Potential Creatinine.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/49706-siemens-dimension-creatinine-flex-reagent-cartridge-recall-potential-creatinine-measurement. Based on FDA recall #Z-1980-2026 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1980-2026%22&limit=1).

The FDA announced on March 18, 2026, that Siemens Healthcare Diagnostics is recalling Dimension Creatinine Flex reagent cartridges due to potential imprecision in quality control and patient sample results. This defect may lead to erroneously decreased or increased creatinine readings for patients.

How to tell if you have it

Brand: Siemens Healthcare
Product: Dimension Creatinine Flex reagent cartridge (Dimension CRE2)
Material Number: 10872079
Model Number: DF33B
UPC: 00630414595009
Lot Numbers: GA6307, BA7005
Units affected: 18,080

The hazard

The recall covers lots GA6307 and BA7005 because of a potential imprecision in the Dimension CRE2 quality control and patient sample results on the Dimension System. This imprecision may lead to erroneously decreased or increased creatinine patient results.

Context

GovInfoNow's records show Siemens Healthcare Diagnostics, Inc. has 150 other recalls on record since June 7, 2017. Other recent recalls of similar products include Atellica CH Revised C-Reactive Protein (RCRP) (Aug. 17, 2026), Siemens Healthcare Syva EMIT 2000 Quinidine Assay Recall (July 13, 2026), and Siemens Atellica CH Urine Albumin Recall (July 6, 2026). Other recent recalls of similar products include HardyDisk AST Cefiderocol 30μg FDC30 (June 8, 2026), Medtronic HR-ACT Cartridges Recall (Oct. 20, 2025), and Changchun Wancheng Bio-Electron UTI Test Strips Recall (Nov. 22, 2025).

How to tell if you have this one

Check the lot number on the cartridge label. Affected lots are GA6307 and BA7005. These cartridges were sold with model number DF33B and material number 10872079.

Brand
Siemens Healthcare
Product
Dimension Creatinine Flex reagent cartridge. Material Number: 10872079
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Lot Number
Look for lot numbers GA6307 or BA7005 on the cartridge label.

Where it went and when

Where it was distributed

Distributed nationwide, and outside the U.S.

FDA distribution: “Worldwide distribution - US Nationwide and the countries of Argentina, Australia, Austria, Bahamas, Brazil, Cambodia, Canada, Chile, China, Columbia, Costa Rica, Ecuador, Egypt, Germany, Honduras, India, Indonesia, Korea, Kuwait, Lebanon,…” 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 published this recall 49 days after the firm started it.

Mar 18, 2026Firm started the recall
Apr 28, 2026FDA classified it Class II
May 6, 2026Published in FDA’s Enforcement Report

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

✎ GovInfoNow

Questions people ask

From the GovInfoNow team · based on the FDA notice · How we make summaries

Do I need to stop using these cartridges immediately?

No immediate stop is required, but you should check the lot number and contact your lab if you have the affected lots.

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Link to this recall

<a href="https://govinfonow.com/recall/49706-siemens-dimension-creatinine-flex-reagent-cartridge-recall-potential-creatinine-measurement">Siemens Dimension Creatinine Flex Reagent Cartridge Recall: Potential Creatinine (GovInfoNow)</a>

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-1980-2026 (March 18, 2026) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1980-2026 to see it in context.
Plain-language summary written by qwen3:4b on August 18, 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.