FDAMarch 18, 2026device
Dimension Creatinine Flex reagent cartridge. Material Number: 10872079.
Official recall recorded by the U.S. Food & Drug Administration.
The 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
What to do
FDA enforcement status: Ongoing
Brands named
siemens healthcare diagnosticssiemenssiemens healthcare
UPCs
00630414595009
Recall history
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