Agency classClass IIOur severity:Moderate FDA (Devices)·Z-1654-2018·Announced 2018-05-16

Siemens Dimension Thyroxine Assay Recalled for Drug Interference

Siemens Healthcare Diagnostics is recalling Dimension Thyroxine assays because they may produce inaccurate results when used with certain drugs.

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 the hazard involves potential diagnostic errors due to drug interference without reported injuries or illnesses, fitting the criteria for a moderate severity precautionary recall.

Plain-English summary

Siemens Healthcare Diagnostics, Inc. is recalling the Dimension Thyroxine (T4) assay (Product Number: DF65/10444908). The recall involves 10,056 units of the product, which is used to measure chemical levels in blood, urine, or cerebrospinal fluid.

The recall was initiated because the assay may interfere with the drugs sulfasalazine and/or sulfapyridine. This interference can cause falsely elevated or falsely depressed test results, potentially leading to incorrect medical interpretations.

The affected products were distributed in all 50 U.S. states, the District of Columbia, Guam, and Puerto Rico, as well as in 108 foreign countries. All lots of the product are included in this recall. Healthcare facilities and laboratories should stop using the affected assays and contact Siemens Healthcare Diagnostics for further instructions.

The recalled product

Product: Dimension Thyroxine (T4) assay (Product Number: DF65/10444908) (Mfr: Siemens Healthcare Diagnostics, Newark, DE)
Manufacturer: Siemens Healthcare Diagnostics, Inc.
Category: Medical Device — In Vitro Diagnostics
Hazard: diagnostic-error
drug-interference
Affected units: 10,056

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 (1)

All lots

Distribution

Distributed in 3 states:

Part of a larger recall action

This product is one of 17 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 17 products in this recall →

Same manufacturer · Siemens Healthcare Diagnostics, Inc.

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