Siemens Uric Acid Assay Recalled Due to Drug Interference
Siemens Healthcare Diagnostics is recalling Dimension Uric Acid assays because N-Acetylcysteine and Metamizole can cause falsely low 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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a risk-of-harm product (medical diagnostic device) where inaccurate results could lead to clinical mismanagement, but no specific injuries or illnesses have been reported in the source text.
Plain-English summary
Siemens Healthcare Diagnostics, Inc. is recalling Dimension Assays: Uric Acid (URCA) devices. The recall involves 137,422 units distributed nationwide across the United States and its territories.
The recall was initiated because Siemens identified that N-Acetylcysteine (NAC) and Metamizole (Dipyrone) can interfere with the Trinder and Trinder-like reaction assays used in these devices. This interference may result in falsely depressed uric acid test results for patients receiving these specific medications. NAC is commonly used as an antidote for acetaminophen toxicity.
Healthcare facilities and laboratories should stop using the affected Dimension Uric Acid assays. Siemens has confirmed the interference issue, and the company is managing the recall to prevent inaccurate diagnostic results.
The recalled product
- Product
- Dimension Assays: Uric Acid (URCA)
- Manufacturer
- Siemens Healthcare Diagnostics, Inc.
- 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 # DF77
Distribution
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.
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