The Recall Desk
HighFDA (Devices)·Z-1661-2016·Announced 2016-05-18

Siemens Healthcare Recalls Dimension Assays: Triglycerides (TGL) Due to Interference

Siemens Healthcare Diagnostics is recalling Dimension Assays: Triglycerides (TGL) 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 is classified as FDA Class II, and the hazard involves a risk of harm (falsely depressed diagnostic results) where specific injury or illness has not yet been reported in the source text.

Plain-English summary

Siemens Healthcare Diagnostics, Inc. is recalling Dimension Assays: Triglycerides (TGL) (Catalog # DF69A). The recall involves 137,422 units distributed nationwide across all 50 states, the District of Columbia, Puerto Rico, and U.S. 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 NAC or Metamizole. NAC is the accepted antidote for acetaminophen toxicity.

Healthcare facilities and laboratories should stop using the affected assays and contact Siemens Healthcare Diagnostics for further instructions on handling the recalled units.

The recalled product

Product
Dimension Assays: Triglycerides (TGL)
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: D011286 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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