Siemens Ferritin Reagent Cartridge Recalled for Negative Bias
Siemens Healthcare Diagnostics is recalling 815 Dimension Ferritin Flex reagent cartridges due to negative bias. The affected lot is EA9227.
What this means for you
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: The recall is classified as FDA Class II. The hazard is a negative bias in test results, which is a significant quality issue but does not involve direct physical injury or reported illnesses, fitting the Moderate criteria for low-risk contamination or labeling/quality errors.
Plain-English summary
Siemens Healthcare Diagnostics, Inc. is recalling 815 units of the Dimension Ferritin (FERR) Flex reagent cartridge, catalog number RF440. The recall is limited to lot number EA9227. The product is intended for use on the Dimension RxL clinical chemistry system to measure ferritin in human serum and plasma.
The recall was initiated because the affected lot exhibits negative bias. This defect may result in inaccurate test results, which could affect the diagnosis of diseases affecting iron metabolism, such as hemochromatosis and iron deficiency anemia.
The affected product was distributed worldwide and in specific U.S. states, including AK, AR, AZ, CA, CT, FL, GA, IA, ID, IL, IN, KS, KY, LA, MD, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NY, OK, OR, PR, SD, TN, TX, VA, VT, WA, and WI. Users should stop using the affected lot and contact Siemens Healthcare Diagnostics for further instructions.
The recalled product
- Product
- Dimension¿ Ferritin (FERR) Flex¿ reagent cartridge DM FERR Product Usage: The FERR Flex reagent cartridge is intended to be used on the Dimension RxL clinical chemistry system to quantitatively measure ferritin in human serum and plasma. Measurements of ferritin aid in the d
- Manufacturer
- Siemens Healthcare Diagnostics, Inc.
- Affected units
- 815
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)
- Catalog Number RF440
- SMN# 10444946 Lot # EA9227 UDI: 00842768013867EA922719081510444946840
Distribution
Related recalls
Same manufacturer · Siemens Healthcare Diagnostics, Inc.
See all →- 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
- ModerateSiemens Tricyclic Antidepressant Calibrator/Controls Recall Lot U2
FDA (Devices) · 2026-08-12
- LowSyva Emit Disopyramide Enzyme Immunoassay Calibrator Recalled for Sodium Azide Concentration
FDA (Devices) · 2026-08-12
Same hazard · inaccurate results
See all →- HighHealthmark Protein Test Recalled Due to Expired Ingredient
FDA (Devices) · 2026-09-02
- HighHardyDisk AST Cefiderocol 30µg for In Vitro Testing Recalled Due to Incorrect Cartridges
FDA (Devices) · 2026-08-12
- HighGEM Premier 7000 with iQM3 Blood Analysis Systems Recalled for Solution Concentration Issues
FDA (Devices) · 2026-08-12
- Highepoc BGEM BUN Test Card for epoc Blood Analysis System
FDA (Devices) · 2026-05-06
- HighAbbott i-STAT EG7+ Blood Gas Cartridges Reporting Inaccurate Results
FDA (Devices) · 2026-05-06