Fresh Recalls

Dimension Creatinine Flex reagent cartridge: recall status

Notice names this product. Siemens Healthcare Diagnostics’s Dimension Creatinine Flex reagent cartridge is named in FDA Class II recall Z-1980-2026. Your particular item is not yet verified. Compare the identifiers and exclusions in the notice before deciding whether it applies. Agency-reported hazard: 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 Identifying details: Material Number: 10872079. Model Number: DF33B. UDI: (01)00630414595009(10)GA6307(17)20261103, (01)00630414595009(10)BA7005(17)20270105. Lot Numbers: GA6307, BA7005.. Units affected: 18,080 units. Status: Ongoing.

1. Compare your item

This notice names a product; your particular item is not yet verified. Compare every applicable model, serial, lot, production-date or model-year boundary below.

Product named
Dimension Creatinine Flex reagent cartridge
Company / brand
Siemens Healthcare Diagnostics
Lot / serial / date codes
Material Number: 10872079. Model Number: DF33B. UDI: (01)00630414595009(10)GA6307(17)20261103, (01)00630414595009(10)BA7005(17)20270105. Lot Numbers: GA6307, BA7005.
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.
Agency product description and boundaries

Dimension Creatinine Flex reagent cartridge. Material Number: 10872079.

Still to verify: match the label on your item with the full official notice, including any exclusions, tables and photos. Some identifiers appear only on the agency website and are absent from this data feed. A missing field does not mean all versions are affected.

If your lot or date falls outside a stated range, this notice has not established that your item is affected. This is not a finding about other recalls or product safety.

Brand
Siemens Healthcare Diagnostics

Recalls naming this model

FDA Class II · Medical device · May 6, 2026

Dimension Creatinine Flex reagent cartridge recall — Siemens Healthcare Diagnostics, Inc.

Siemens Healthcare Diagnostics is recalling certain lots of Dimension Creatinine Flex reagent cartridge (Dimension CRE2) because a potential imprecision in the Dimension CRE2 quali…

Company / brand: Siemens Healthcare Diagnostics

Affected product: Dimension Creatinine Flex reagent cartridge

Official ID Z-1980-2026 · Official record ↗

See all Siemens Healthcare Diagnostics recalls →

Verify with the official sources:

Found something wrong or missing? Report a data error.

Compiled from connected official public-domain government data. Sources last checked September 7, 2026 at 6:00 AM UTC.