Agency classClass IIOur severity:High FDA (Devices)·Z-1665-2016·Announced 2016-05-18

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.

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 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.
Category: Medical Device — In Vitro Diagnostics
Hazard: interference
incorrect-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: D011436 - Triglycerides (TGL)
Catalog # DF69A

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 · interference