Z-1980-2026Class II

Dimension Creatinine Flex reagent cartridge. Material Number: 10872079

Name: Z-1980-2026 Dimension Creatinine Flex reagent cartridge. Material Number: 10872079
Creator: Siemens Healthcare Diagnostics, Inc.
Published: 2026-03-18
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2026-03-18 / Open, Classified

FDA source

Siemens Healthcare Diagnostics, Inc. began a recall of Dimension Creatinine Flex reagent cartridge. Material Number: 10872079 on 2026-03-18. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-1980-2026
Classification: Class II
Status: Open, Classified
Initiated: 2026-03-18
Posted: 2026-04-28
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: Dimension Creatinine Flex reagent cartridge. Material Number: 10872079.
Product code: CGX Alkaline Picrate, Colorimetry, Creatinine
Reason for 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
FDA root cause: Under Investigation by firm
Action: Siemens Healthineers notified consignees on about 03/18/2026 via letter. Consignees were notified of the issue, the hazard involved and instructed to immediately discontinue use of and discard the affected kit lots, each facility should review the recall notification with their Medical Director to determine the appropriate course of action, including for any previously generated results, if applicable, and review inventory to determine the laboratory's replacement needs and communicate that with Siemens Healthineers. Consignees were also instructed to complete and return the Field Correction Effectiveness Check Form provided and retain the letter with laboratory records and forward it to anyone how may have received or used the affected product.
Quantity in commerce: 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.
Product codes and lots: Material Number: 10872079. Model Number: DF33B. UDI: (01)00630414595009(10)GA6307(17)20261103, (01)00630414595009(10)BA7005(17)20270105. Lot Numbers: GA6307, BA7005.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1980-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1980-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-05-06	2026-04-28

Product code CGX

K132638Class IIDimension Creatinine (Cre2) Flex Reagent CartridgeSiemens Healthcare Diagnostics, Inc. / cleared 2014-01-27

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)