HIGH

Dimension Creatinine Flex reagent cartridge. Material Number: 10872079.

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

Quick Facts at a Glance

Recall Date
March 18, 2026
Hazard Level
HIGH
Brand
Siemens Healthcare Diagnostics
Geographic Scope
1 states

Hazard Information

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

What You Should Do

Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Siemens Healthcare Diagnostics, Inc. or your healthcare provider for instructions. Notification method: Letter

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Full Description

Dimension Creatinine Flex reagent cartridge. Material Number: 10872079.. Reason: 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. Classification: Class II. Quantity: 18,080 units. 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, Malaysia, Mexico, Nicaragua, Pakistan, Paraguay, Philippines, Qatar, Saudi Arabia, Serbia, Slovenia, South Africa, Sri Lanka, Taiwan, Thailand, U.A.E., Ukraine, Uruguay, Vietnam, Yemen.

View Original Recall on FDA - Medical Devices

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Product Classification

Product Details

Model Numbers
Material Number: 10872079. Model Number: DF33B. UDI: (01)00630414595009(10)GA6307(17)20261103
(01)00630414595009(10)BA7005(17)20270105. Lot Numbers: GA6307
BA7005.
Affected States
ALL
Report Date
May 6, 2026
Recall Status
ACTIVE

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