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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 (Material Number 10872079, Dimension CRE2) due to potential imprecision in quality control and patient sample results for lot numbers GA6307 and BA7005 on the Dimension System. This imprecision may lead to erroneously decreased or increased creatinine patient results.

Is mine affected?

Check the model, lot, or serial number on the device or its packaging. Yours is affected if it matches one below.

Dimension Creatinine Flex reagent cartridge. Material Number: 10872079.

UPC
10872079, 00630414595009, 20261103, 00630414595009, 20270105
Recall #
Z-1980-2026

Where it was sold

Distributed nationwide.

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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