Dimension Creatinine Flex Reagent Cartridge Recalled for Imprecision Results
Siemens Healthcare Diagnostics is recalling certain lots of Dimension Creatinine Flex reagent cartridges due to potential imprecision in creatinine test results that could be erroneously increased or decreased.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is an FDA Class II recall with no reported illnesses or injuries mentioned in the source. The hazard is a potential imprecision in test results rather than a confirmed failure, making this a moderate precautionary action warranting timely correction but not meeting criteria for higher severity.
Plain-English summary
Siemens Healthcare Diagnostics is recalling 18,080 units of Dimension Creatinine Flex reagent cartridges (Material Number 10872079, Model DF33B) with lot numbers GA6307 and BA7005. The recall affects units distributed worldwide, including nationwide in the United States and internationally to Argentina, Australia, Austria, Bahamas, Brazil, Cambodia, Canada, Chile, China, Colombia, Costa Rica, Ecuador, Egypt, Germany, Honduras, India, Indonesia, Korea, Kuwait, Lebanon, Malaysia, Mexico, Nicaragua, Pakistan, Paraguay, Philippines, Qatar, Saudi Arabia, Serbia, Slovenia, South Africa, Sri Lanka, Taiwan, Thailand, the United Arab Emirates, Ukraine, Uruguay, Vietnam, and Yemen.
The cartridges are being recalled because of a potential imprecision in quality control and patient sample results on the Dimension System. This imprecision may cause creatinine patient results to be erroneously decreased or increased.
Healthcare facilities using affected lot numbers should contact Siemens Healthcare Diagnostics for instructions on replacement cartridges and proper handling of affected units.
The recalled product
- Product
- Dimension Creatinine Flex reagent cartridge. Material Number: 10872079.
- Manufacturer
- Siemens Healthcare Diagnostics, Inc.
- Affected units
- 18,080
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- (01)00630414595009(10)BA7005(17)20270105. Lot Numbers: GA6307
- BA7005.
Distribution
Distributed nationwide across the United States.
Related recalls
Same manufacturer · Siemens Healthcare Diagnostics, Inc.
See all →- HighSiemens Atellica CH C-Reactive Protein Reagent Recalled for Falsely Elevated Results
FDA (Devices) · 2026-10-07
- SevereSiemens Recalls Emit 2000 Quinidine Assay Due to Precision Issues
FDA (Devices) · 2026-08-26
- SevereSiemens Quinidine Assay Recalled for Precision Errors
FDA (Devices) · 2026-08-26
- HighSiemens Atellica CH Urine Albumin In Vitro Diagnostic Recall
FDA (Devices) · 2026-08-12
- LowSyva Emit Disopyramide Enzyme Immunoassay Calibrator Recalled for Sodium Azide Concentration
FDA (Devices) · 2026-08-12
Same hazard · test imprecision
See all →- HighMedical Device Reagent Recalled for Unreliable Test Results
FDA (Devices) · 2023-11-22
- HighIMMULITE 2000 Thyroglobulin Diagnostic Kit Accuracy Issues
FDA (Devices) · 2023-01-18
Similar recalls
- HighSiemens Dimension Vista Calcium Reagent Cartridge Recall for Erroneous Results
FDA (Devices) · 2016-10-12
- HighSiemens Recalls Dimension Gentamicin Flex Reagent Cartridges Due to Inaccuracy
FDA (Devices) · 2018-06-20
- HighSiemens magnesium reagent cartridges recalled for false measurement results
FDA (Devices) · 2025-01-01
- HighSiemens Magnesium Flex reagent cartridge recalled for imprecision and assay errors
FDA (Devices) · 2022-04-06
- HighSiemens Dimension Vista Calcium Flex Reagent Cartridge Recalled for Low Results
FDA (Devices) · 2018-05-09
- HighSiemens Dimension Vista Magnesium Reagent Cartridge Recall for Low Results
FDA (Devices) · 2015-12-02