Siemens Healthcare Diagnostics, Inc. recalls Dimension Creatinine Flex reagent cartridge. Material Number: 10872079.

Recalling company

Siemens Healthcare Diagnostics, Inc.

Product

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 – may cause temporary or medically reversible health consequences

Recall date

Mar 18, 2026

Reported

May 6, 2026

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.

Status

Ongoing

Quantity

18,080 units

Lot / codes

Material Number: 10872079. Model Number: DF33B. UDI: (01)00630414595009(10)GA6307(17)20261103, (01)00630414595009(10)BA7005(17)20270105. Lot Numbers: GA6307, BA7005.

Company location

Newark, DE

Recall type

Voluntary: Firm initiated

Recall number

Z-1980-2026

Agency

U.S. Food and Drug Administration (FDA)

View official FDA notice ↗ Search recall number Z-1980-2026 in the FDA Enforcement Report. Also see FDA recall press releases.