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.
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 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.
- Hazard
- 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
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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