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.
What this means for you
Illness, injury, or structural failure has been reported. 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.
- 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
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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