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Dimension Creatinine Flex Reagent Cartridge
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MEDICAL DEVICE RECALLMODERATE

Dimension Creatinine Flex Reagent Cartridge

Siemens is recalling Dimension Creatinine Flex reagent cartridges (lots GA6307, BA7005) due to potential imprecision in patient creatinine results.

What to do

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.

Posted
Updated
Recall No.
Z-1980-2026
Agency
Firm
Siemens Healthcare Diagnostics, Inc.
Recall ID
98666
Status
ONGOING

Why it was recalled

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

How to identify it

UPC 10872079 00630414595009 20261103 00630414595009 20270105

Dimension Creatinine Flex reagent cartridge. Material Number: 10872079.

Where it was sold

Distributed in US.

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Editorial summary by Recall Canary · last updated 2026-04-29 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification