FDA DeviceClass IINotable

FDA Recall: Dimension Creatinine Flex reagent cartridge. Material Number: 10872079.

Date: 2026-05-06
Brand: Siemens Healthcare Diagnostics, Inc.
Category: Medical Device
FDA Class: Class II

Description

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

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

Remedy

18,080 units

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