Reported May 6, 2026 · Ongoing
Dimension Creatinine Flex reagent cartridge. Material Number: 10872079.
Siemens Healthcare Diagnostics, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Siemens Healthcare Diagnostics, Inc. · 500 Gbc Dr · Newark, DE · 19702-2466
Is this the product you have?
- Dimension Creatinine Flex reagent cartridge
- Material Number10872079
- Lot codes and dates
- Material Number10872079
- Model NumberDF33B
- UDI
(01)00630414595009(10)GA6307(17)20261103(01)00630414595009(10)BA7005(17)20270105
- Lot Numbers
GA6307BA7005
- Amount recalled
- 18,080 units
Where it was sold
- Nationwide
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
This product could cause temporary or reversible health problems — stop using it.
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