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Medical Device

Dimension Creatinine Flex reagent cartridge. Material Number: 10872079.

Recall date: 2026-05-06 · Source: FDA_DEVICE
Brand / Firm
Siemens Healthcare Diagnostics, Inc.
Product
Dimension Creatinine Flex reagent cartridge. Material Number: 10872079.
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
Units affected
18,080 units
Description
Dimension Creatinine Flex reagent cartridge. Material Number: 10872079.
View official recall notice →