Agency classClass IIOur severity:Moderate FDA (Devices)·Z-2608-2017·Announced 2017-06-28

Siemens Dimension Vista Estradiol Reagent Cartridge Recall for Labeling Error

Siemens Healthcare Diagnostics is recalling Dimension Vista Estradiol reagent cartridges because the instructions for use contain incorrect biotin interference units.

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, which typically corresponds to a moderate severity score. The issue is a labeling error regarding interference levels, which is a documentation issue rather than a direct physical hazard or confirmed injury.

Plain-English summary

Siemens Healthcare Diagnostics, Inc. is recalling 1,697 units of Dimension Vista Estradiol (E2) 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 Estradiol (E2). The IFU lists incorrect units for Biotin 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 the United Arab Emirates, Argentina, Austria, Australia, and others. The specific lot numbers involved are 16148AA, 16190BA, 16201BA, 16228BC, 16256BA, 16277BB, 16298AB, 16343BE, and 17005BC. The Device Listing Number is D121541.

Healthcare facilities and users should check their inventory for these specific lot numbers and stop using the affected cartridges. Siemens Healthcare Diagnostics, Inc. is the recalling firm and is responsible for managing the recall process.

The recalled product

Product: Dimension Vista Estradiol (E2) Flex reagent cartridge
Manufacturer: Siemens Healthcare Diagnostics, Inc.
Category: Medical Device — In Vitro Diagnostics
Hazard: mis-labeling
Affected units: 1,697

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 (8)

Device Listing Number # D121541 Lot # 16148AA
16190BA
16201BA
16228BC
16256BA
16277BB 16298AB
16343BE
17005BC

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