Siemens Uric Acid Assay Recalled Due to Interference
Siemens Healthcare Diagnostics is recalling Uric Acid assays because N-Acetylcysteine and Metamizole can cause falsely depressed results.
What this means for you
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 source text does not report any hospitalizations, injuries, or deaths, fitting the criteria for a moderate severity score.
Plain-English summary
Siemens Healthcare Diagnostics, Inc. is recalling Advia Chemistry Assay: Uric Acid and Uric Acid, concentrated. The recall involves 13,742 units distributed nationwide to various states and territories. The specific device listings are Uric Acid (UA) - D033081, Catalog # 74021 and Uric Acid, concentrated (UA_c) - D033081, Catalog # 74715.
The recall is due to interference from N-Acetylcysteine (NAC) and Metamizole (Dipyrone) in Trinder and Trinder-like reaction assays. Siemens has confirmed that falsely depressed results may occur on samples drawn from patients receiving these medications. NAC is the accepted antidote for acetaminophen toxicity.
Healthcare facilities and laboratories should stop using the affected assays and contact Siemens Healthcare Diagnostics for instructions on how to return the product.
The recalled product
- Product
- Advia Chemistry Assay: Uric Acid and Uric Acid, concentrated
- 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 (4)
- Device Listing: Uric Acid (UA) - D033081
- Catalog # 74021 and Uric Acid
- concentrated (UA_c) - D033081
- Catalog # 74715
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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