fda_recall · device_recall · high

Siemens Healthcare Diagnostics, Inc. — Class II recall: Dimension Creatinine Flex reagent cartridge. Material Number: 10872079.

Event date: 2026-05-06 00:00:00Z
Observed: 2026-07-09 22:52:46Z
Source ID: Z-1980-2026
Payload hash: fe84f250d431b5494ac181e7…

Summary

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… Status: Ongoing.

Entities

Siemens Healthcare Diagnostics, Inc.

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Informational only. Not legal, financial, or medical advice.