Agency classClass IIOur severity:High FDA (Devices)·Z-1653-2016·Announced 2016-05-18

Siemens Recalls Direct HDL Cholesterol Assay Due to Interference

Siemens Healthcare Diagnostics is recalling the Advia Chemistry Assay: Direct HDL Cholesterol due to potential falsely depressed results caused by NAC or Metamizole interference.

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 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall is classified as FDA Class II. The hazard involves falsely depressed test results which could lead to incorrect medical decisions, representing a risk of harm where injury has not yet been reported.

Plain-English summary

Siemens Healthcare Diagnostics, Inc. is recalling the Advia Chemistry Assay: Direct HDL Cholesterol (D-HDL). The recall involves 137,422 units of the device, which were distributed nationwide to various states and territories, including Puerto Rico, Guam, and the Pacific Mariana Islands.

The recall was initiated because Siemens became aware of interference from N-Acetylcysteine (NAC) and Metamizole (Dipyrone) with Trinder and Trinder-like reaction assays. The company confirmed that falsely depressed results may occur on samples drawn from patients receiving NAC or Metamizole. NAC is the accepted antidote for acetaminophen toxicity.

Healthcare facilities and laboratories should stop using the affected assay and contact Siemens Healthcare Diagnostics for further instructions on the recall process.

The recalled product

Product: Advia Chemistry Assay: Direct HDL Cholesterol (D-HDL)
Manufacturer: Siemens Healthcare Diagnostics, Inc.
Category: Medical Device — In Vitro Diagnostic
Hazard: test-interference
inaccurate-results
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: Direct HDL Cholesterol: D126055
Catalog # 74073

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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Same hazard · test interference