Agency classClass IIOur severity:Moderate FDA (Devices)·Z-2609-2017·Announced 2017-06-28

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.

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, 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.
Category: Medical Device — In Vitro Diagnostics
Hazard: mis-labeling
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.

See all 6 products in this recall →

Same manufacturer · Siemens Healthcare Diagnostics, Inc.

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Same hazard · mis labeling