Siemens Dimension Vista Triglyceride Assay Recalled for Interference
Siemens is recalling Dimension Vista Triglyceride 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 where a defect (interference) can lead to incorrect clinical results (falsely depressed triglycerides), posing a risk of harm to patients, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
Siemens Healthcare Diagnostics, Inc. is recalling Dimension Vista Assays: Triglycerides (TRIG) (Catalog # DF69A). The recall involves 137,422 units distributed nationwide to various states and territories.
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 these specific medications. NAC is noted as the accepted antidote for acetaminophen toxicity.
Healthcare facilities and laboratories should stop using the affected assays and contact Siemens for further instructions regarding the recall.
The recalled product
- Product
- Dimension Vista Assays: Triglycerides (TRIG)
- 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: D011436 - Triglycerides (TGL)
- Catalog # DF69A
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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