Siemens Direct HDL Cholesterol Assay Recalled for Interference
Siemens Healthcare Diagnostics is recalling Direct HDL Cholesterol assays because N-Acetylcysteine and Metamizole can cause falsely depressed results.
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 involves a medical device that can produce inaccurate diagnostic results, posing a risk of harm through misdiagnosis or delayed treatment, but no specific injuries or illnesses have been reported in the source text.
Plain-English summary
Siemens Healthcare Diagnostics, Inc. is recalling Dimension Vista Assays: Direct HDL Cholesterol (AHDL) due to potential interference from N-Acetylcysteine (NAC) and Metamizole (Dipyrone). The recall affects 137,422 units distributed nationwide across all 50 states, the District of Columbia, Puerto Rico, and U.S. territories.
Siemens has confirmed that falsely depressed results may occur on samples drawn from patients receiving NAC or Metamizole. NAC is the accepted antidote for acetaminophen toxicity. The interference affects Trinder and Trinder-like reaction assays.
Healthcare facilities and laboratories should stop using the affected assays and contact Siemens Healthcare Diagnostics for further instructions. Patients who have had recent HDL cholesterol tests while receiving NAC or Metamizole should consult their healthcare provider to discuss the potential impact on their results.
The recalled product
- Product
- Dimension Vista Assays: Direct HDL Cholesterol (AHDL)
- 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 (1)
- Device Listing: D056475 Direct HDL Cholesterol (TRIG) Catalog # K3048A
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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