Agency classClass IIOur severity:Severe FDA (Devices)·Z-1666-2016·Announced 2016-05-18

Siemens Uric Acid Assays Recalled Due to Drug Interference

Siemens Healthcare Diagnostics is recalling Dimension Vista Uric Acid assays because NAC and Metamizole can cause falsely depressed 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 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall is classified as FDA Class II, which corresponds to a 'Severe' severity score per the rubric, as it involves a significant risk of adverse health consequences due to inaccurate diagnostic results.

Plain-English summary

Siemens Healthcare Diagnostics, Inc. is recalling Dimension Vista Assays: Uric Acid (URCA) due to interference from N-Acetylcysteine (NAC) and Metamizole (Dipyrone). The company confirmed that falsely depressed results may occur on samples drawn from patients receiving these medications.

The recall involves 137,422 units distributed nationwide across all 50 states, the District of Columbia, Puerto Rico, and U.S. territories. The affected product is identified by Device Listing D011436 and Catalog # K1077.

This recall is classified as Class II by the FDA. Patients receiving NAC or Metamizole may receive inaccurate uric acid test results, which could impact clinical decision-making.

The recalled product

Product: Dimension Vista Assays: Uric Acid (URCA)
Manufacturer: Siemens Healthcare Diagnostics, Inc.
Category: Medical Device — In Vitro Diagnostics
Hazard: inaccurate-results
drug-interference
Affected units: 137,422

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 (2)

Device Listing: D011436 - Uric Acid (URCA)
Catalog # K1077

Distribution

Distributed nationwide across the United States.

The notice also names 52 states specifically:

Part of a larger recall action

This product is one of 16 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 16 products in this recall →

Same manufacturer · Siemens Healthcare Diagnostics, Inc.

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Same hazard · inaccurate results