Agency classClass IIOur severity:Moderate FDA (Devices)·Z-1652-2016·Announced 2016-05-18

Siemens LDL Cholesterol Assay Recalled for Interference

Siemens is recalling Advia Chemistry Assay: LDL Cholesterol, Direct because N-Acetylcysteine 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 2/5 (Moderate).

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 describes a diagnostic interference issue (falsely depressed results) rather than a direct physical injury or hospitalization event, fitting the criteria for moderate severity.

Plain-English summary

Siemens Healthcare Diagnostics, Inc. is recalling the Advia Chemistry Assay: LDL Cholesterol, Direct. The recall involves 137,422 units distributed nationwide across all 50 states, the District of Columbia, and several U.S. territories.

The recall was initiated because Siemens confirmed that N-Acetylcysteine (NAC) and Metamizole (Dipyrone) can interfere with the assay. This interference may result in falsely depressed LDL cholesterol measurements for patients receiving these specific medications. NAC is noted as the accepted antidote for acetaminophen toxicity.

Healthcare providers and laboratories should stop using the affected assay kits. Siemens is the recalling firm responsible for managing the recall process.

The recalled product

Product: Advia Chemistry Assay: LDL Cholesterol, Direct
Manufacturer: Siemens Healthcare Diagnostics, Inc.
Category: Medical Device — In Vitro Diagnostic
Hazard: diagnostic-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 (3)

Device Listing: LDL Cholesterol
Direct: D126056
Catalog # 74028

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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