Dimension Creatinine Flex Reagent Cartridge
Siemens is recalling Dimension Creatinine Flex reagent cartridges (lots GA6307, BA7005) due to potential imprecision in patient creatinine results.
Stop using affected lot numbers GA6307 and BA7005 immediately. Contact Siemens Healthcare Diagnostics for instructions on replacement cartridges and verification of results from affected lots.
Recall at a glance
- Quantity recalled
- 18,080 units
Why it was recalled
Siemens Healthcare Diagnostics is recalling certain lots of Dimension Creatinine Flex reagent cartridge (Material Number 10872079, Dimension CRE2) due to potential imprecision in quality control and patient sample results for lot numbers GA6307 and BA7005 on the Dimension System. This imprecision may lead to erroneously decreased or increased creatinine patient results.
Is mine affected?
Check the model, lot, or serial number on the device or its packaging. Yours is affected if it matches one below.
Dimension Creatinine Flex reagent cartridge. Material Number: 10872079.
- UDI-DI
- 10872079, 00630414595009, 20261103, 00630414595009, 20270105
Where it was sold
Distributed nationwide.
Timeline
- Firm initiated recall
- Publicly announced
- Listed on Recall Canary
- Summary updated
Official source
Other recent recalls from Siemens Healthcare Diagnostics, Inc.
Editorial summary by Recall Canary · summary updated 2026-04-29 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification