Agency classClass IIOur severity:Moderate FDA (Devices)·Z-2611-2017·Announced 2017-06-28

Siemens Dimension Vista TSH Reagent Cartridge Recall for Incorrect Biotin Units

Siemens is recalling Dimension Vista TSH 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 and involves a labeling/documentation error regarding biotin interference levels, which fits the criteria for minor labeling errors or low-risk contamination without reported injuries.

Plain-English summary

Siemens Healthcare Diagnostics, Inc. is recalling 19,927 units of the Dimension Vista Thyroid Stimulating Hormone (TSH) Flex reagent cartridge. The recall involves specific lots including 16118BD, 16159BA, 16193BC, 16193BD, 16208AA, 16251BA, 16277BD, 16322BB, 17005BB, and 17023AC. The product was distributed throughout the United States, Canada, and numerous international locations.

The recall was initiated because the Non-Interfering Substances section of the current Instructions for Use (IFU) for the Dimension and Dimension Vista TSH reagent cartridges contains errors. Specifically, the concentrations for Biotin are listed with incorrect units and incorrectly state the level at which biotin does not interfere with the test results. This documentation error affects the Dimension TNI, Dimension Vista DIGXN, E2, FERR, PRL, and TSH reagents.

Healthcare facilities and laboratories that possess these specific reagent cartridges should stop using them and contact Siemens Healthcare Diagnostics for instructions on how to return the product. The recall is classified as Class II by the FDA.

The recalled product

Product: Dimension Vista Thyroid Stimulating Hormone (TSH) Flex reagent cartridge
Manufacturer: Siemens Healthcare Diagnostics, Inc.
Category: Medical Device — In Vitro Diagnostics
Hazard: 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 (9)

Device Listing Number # D230089 Lot # 16118BD
16159BA
16193BC
.16193BD
16208AA
16251BA 16277BD
16322BB
17005BB
17023AC

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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