Agency classClass IIOur severity:Moderate FDA (Devices)·Z-1659-2016·Announced 2016-05-18

Siemens Direct HDL Cholesterol Assay Recalled for Interference

Siemens is recalling Direct HDL Cholesterol assays 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: This is an FDA Class II recall involving a diagnostic device where the hazard is inaccurate test results rather than direct physical injury, fitting the criteria for moderate severity.

Plain-English summary

Siemens Healthcare Diagnostics, Inc. is recalling Dimension Assays: Direct HDL Cholesterol (AHDL) due to interference from N-Acetylcysteine (NAC) and Metamizole (Dipyrone). The company confirmed that these substances can cause falsely depressed results on samples drawn from patients receiving these medications.

The recall covers 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 D 044702 and Catalog # DF48B.

Healthcare facilities should stop using the affected assays and contact Siemens for further instructions. Patients who have received test results using this assay while taking NAC or Metamizole should consult their healthcare provider to discuss the potential for inaccurate results.

The recalled product

Product: Dimension Assays: Direct HDL Cholesterol (AHDL)
Manufacturer: Siemens Healthcare Diagnostics, Inc.
Category: Medical Device — In Vitro Diagnostic
Hazard: inaccurate-results
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 (2)

Device Listing: D 044702 - Direct HDL Cholesterol (AHDL)
Catalog # DF48B

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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