The Recall Desk
ModerateFDA (Devices)·Z-1658-2016·Announced 2016-05-18

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
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

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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