Agency classClass IIOur severity:Moderate FDA (Devices)·Z-2610-2017·Announced 2017-06-28

Siemens Dimension Vista Prolactin Reagent Cartridge Recall for Labeling Error

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

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 involves a labeling error regarding biotin interference levels. Per the rubric, minor labeling errors and voluntary precautionary recalls without reported injuries or illnesses fall under the Moderate severity category.

Plain-English summary

Siemens Healthcare Diagnostics, Inc. is recalling 3,443 units of Dimension Vista Prolactin (PRL) Flex reagent cartridges. The recall is due to a labeling error in the Instructions for Use (IFU) for several Dimension and Dimension Vista assays, including Prolactin. The Non-Interfering Substances section of 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 specific lot numbers involved are 16112BB, 16148BA, 16165BE, 16195BA, 16223AD, 16259BC, 16285BE, 16312BD, 16334BE, 17004BA, and 17038BC. The Device Listing Number is A836016.

This is a Class II recall, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences. Healthcare providers and laboratories should verify their inventory against the listed lot numbers and contact Siemens Healthcare Diagnostics for further instructions on how to handle the affected units.

The recalled product

Product: Dimension Vista Prolactin (PRL) Flex reagent cartridge
Manufacturer: Siemens Healthcare Diagnostics, Inc.
Category: Medical Device — In Vitro Diagnostics
Hazard: mis-labeling
Affected units: 3,443

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 (10)

Device Listing Number # A836016 Lot # 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