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.
What this means for you
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.
- 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
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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