Siemens Ferritin Cartridge Recalled for Incorrect Biotin Interference Labeling
Siemens Healthcare Diagnostics is recalling Dimension Vista Ferritin reagent cartridges because the instructions for use contain incorrect units and levels for biotin interference.
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, but the source text identifies the issue as a labeling error regarding interference units and levels without reporting any illnesses, injuries, or adverse health consequences. This aligns with the rubric for minor labeling errors or low-risk issues.
Plain-English summary
Siemens Healthcare Diagnostics, Inc. is recalling 29,266 units of Dimension Vista Ferritin (FERR) Flex reagent cartridges. The recall is due to an error in the Non-Interfering Substances section of the Instructions for Use (IFU) for several Dimension and Dimension Vista assays, including Ferritin. The IFU lists incorrect units and incorrectly states the level at which biotin does not interfere with the test results.
The affected product was distributed throughout the United States, Canada, and numerous international locations including countries in Europe, Asia, the Middle East, and South America. The recall covers specific lot numbers, including 16102BF, 16144BB, and 16196BD, among others.
Consumers and healthcare facilities should stop using the affected cartridges and contact Siemens Healthcare Diagnostics for further instructions or replacement. This recall addresses a labeling and documentation error regarding interference limits rather than a defect in the physical cartridge itself.
The recalled product
- Product
- Dimension Vista Ferritin (FERR) Flex reagent cartridge
- Manufacturer
- Siemens Healthcare Diagnostics, Inc.
- Hazard
- Affected units
- 29,266
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 (20)
- Device Listing Number # D011479 Lot # 16102BF
- 16144BB
- 16196BD
- 16201BF
- 16214BF
- 16236BA 16252AB
- 16277BC
- 16284AB
- 17012BC
- 17012BD
- 17034BA
- 16112BB 16148BA
- 16165BE
- 16195BA
- 16223AD
- 16259BC
- 16285BE
- 16312BD 16334BE
- 17004BA
- 17038BC
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 6 recalled by Siemens Healthcare Diagnostics, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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