Siemens Hemoglobin A1c Reagent Cartridges Recalled for Positive Bias
Siemens is recalling certain lots of Dimension HB1C Flex reagent cartridges because they show a positive bias in hemoglobin A1c measurements.
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, and the hazard involves measurement bias rather than direct physical injury or contamination, fitting the criteria for moderate severity.
Plain-English summary
Siemens Healthcare Diagnostics, Inc. is recalling certain lots of Siemens Dimension HB1C Flex reagent cartridges and Siemens Dimension Vista HbA1c Flex reagent cartridges. These products are in vitro diagnostic assays used on the Dimension clinical chemistry system to measure hemoglobin A1c (HbA1c) in human anticoagulated whole blood. The recall involves 53,046 units distributed nationwide in the United States and internationally to Canada.
The recall was initiated because certain lots of the reagent cartridges show a confirmed positive bias averaging 0.4% Hemoglobin A1c units and occasionally up to 1.0% HbA1c units for patient samples when compared to the National Glycohemoglobin Standardization Program (NGSP). Quality control samples may also exhibit a similar bias. This bias could lead to inaccurate monitoring of long-term glucose control in individuals with diabetes mellitus.
Healthcare facilities and laboratories should stop using the affected lots and contact Siemens Healthcare Diagnostics, Inc. for instructions on returning the product. The affected catalog numbers are K3105A and DF105A. Specific lot numbers are listed in the agency's recall notice.
The recalled product
- Product
- Siemens Dimension HB1C Flex reagent cartridge; Dimension Hemoglobin A1c (HB1C) Flex reagent cartridge on the Dimension clinical chemistry system is an in vitro diagnostic assay for the quantitative determination of hemoglobin A1c (HbA1c) in human anticoagulated whole blood.…
- Manufacturer
- Siemens Healthcare Diagnostics, Inc.
- Hazard
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 (3)
- Siemens Dimension Vista HbA1c Flex reagent cartridge: Catalog Number K3105A
- Siemens Material Number (SMN) 10470481
- Siemens Material Number (SMN) 10483822
Distribution
Distributed nationwide across the United States.
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