Agency classClass IIOur severity:Moderate FDA (Devices)·Z-1660-2018·Announced 2018-05-16

Siemens Dimension Vista Thyroxine Assay Recalled for Drug Interference

Siemens is recalling Dimension Vista Thyroxine assays because sulfasalazine and sulfapyridine may cause inaccurate results.

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 hazard is a theoretical risk of inaccurate test results due to drug interference, with no reported injuries or illnesses.

Plain-English summary

Siemens Healthcare Diagnostics, Inc. is recalling the Dimension Vista Thyroxine (T4) assay (Product Number: K6065/10445101). The recall involves 19,991 units distributed in all 50 U.S. states, the District of Columbia, Guam, Puerto Rico, and 108 foreign countries.

The recall was initiated because various assays used to measure chemical levels in blood, urine, or cerebrospinal fluid may interfere with the drugs sulfasalazine and/or sulfapyridine. This interference can cause falsely elevated or falsely depressed results for the Thyroxine (T4) assay.

Healthcare providers and laboratories should stop using the affected products and contact Siemens Healthcare Diagnostics for further instructions. Consumers should consult their healthcare providers regarding any recent test results that may have been affected by this issue.

The recalled product

Product: Dimension Vista Thyroxine (T4) assay; (Product Number: K6065/10445101) (Mfr: Siemens Healthcare Diagnostics, Newark, DE)
Manufacturer: Siemens Healthcare Diagnostics, Inc.
Category: Medical Device — In Vitro Diagnostics
Hazard: inaccurate-results
drug-interference
Affected units: 19,991

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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Same hazard · inaccurate results