Agency classClass IIOur severity:Moderate FDA (Devices)·Z-1671-2018·Announced 2018-05-16

Siemens Cardiac Troponin I Reagent Cartridge Recalled for Biotin Interference

Siemens Healthcare Diagnostics is recalling Dimension Vista Cardiac Troponin I reagent cartridges because they are susceptible to interference from biotin, which is not listed in the instructions for use.

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. The hazard is a labeling omission regarding biotin interference, which is a theoretical risk of inaccurate results rather than a direct physical injury or reported illness, fitting the criteria for a moderate severity voluntary precautionary recall.

Plain-English summary

Siemens Healthcare Diagnostics, Inc. is recalling Dimension Vista Cardiac Troponin I (CTNI) Flex reagent cartridges. The recall is due to the fact that the concentrations of biotin that do not interfere with the test are not currently listed in the instructions for use. The source text indicates that these assays are susceptible to interference from biotin.

The affected products are distributed nationwide in the United States, as well as in Canada, Mexico, and Thailand. The recall includes specific lot codes: 16336BA, 16347BD, 16363BC, 17032AD, 17045BC, 17054BD, 17074BC, 17093BD, 17121BA, 17145BE, 17180BB, 17193BD, 17201BB, 17223BA, and 17264BC.

Healthcare facilities and users of the Dimension Vista system should check their inventory for the affected lot codes. The source text does not provide specific consumer instructions for action beyond the identification of the affected lots and the nature of the hazard.

The recalled product

Product: Dimension Vista¿ Cardiac Troponin I (CTNI) Flex¿ reagent cartridge
Manufacturer: Siemens Healthcare Diagnostics, Inc.
Category: Medical Device — In Vitro Diagnostics
Hazard: biotin-interference
mis-labeling

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 (4)

CTNI
immunoassay method
troponin subunit
K6421

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 24 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 24 products in this recall →

Same manufacturer · Siemens Healthcare Diagnostics, Inc.

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Same hazard · biotin interference