Agency classClass IIOur severity:Moderate FDA (Devices)·Z-2606-2017·Announced 2017-06-28

Siemens Dimension Troponin 1 Cartridge Recall for Incorrect Biotin Labeling

Siemens is recalling Dimension Troponin 1 reagent cartridges because the instructions for use list incorrect units and interference levels for biotin.

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 in the Instructions for Use regarding biotin interference levels, which aligns with the rubric for minor labeling errors or low-risk contamination.

Plain-English summary

Siemens Healthcare Diagnostics, Inc. is recalling 70,428 units of the Dimension Troponin 1 (TNI) Flex reagent cartridge. The recall was initiated because the Non-Interfering Substances section of the current Dimension and Dimension Vistat Instructions for Use (IFU) contains errors regarding biotin. Specifically, 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 other countries including those in Europe, Asia, the Middle East, and South America. The recall covers specific lot numbers: EB7091, EC7104, EA7125, ED7193, EA7161, EB7173, EC7229, ED7236, EA7250, ED7271, EB7315, and EB7342. The device listing number is D056469.

Healthcare facilities and consumers should check their inventory for the specific lot numbers listed above. If the product is found, it should be removed from use and returned to Siemens Healthcare Diagnostics, Inc. according to the company's instructions. This recall addresses a documentation and labeling error in the instructions for use rather than a defect in the physical cartridge itself.

The recalled product

Product: Dimension Troponin 1 (TNI) Flex reagent cartridge
Manufacturer: Siemens Healthcare Diagnostics, Inc.
Category: Medical Device — In Vitro Diagnostics
Hazard: mis-labeling
Affected units: 70,428

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 (11)

Device Listing Number # D056469 Lot # EB7091
EC7104
EA7125
ED7193
EA7161
EB7173
EC7229
ED7236 EA7250
ED7271
EB7315
EB7342 "

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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