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.
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: 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…
- 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
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