The Recall Desk
ModerateFDA (Devices)·Z-1657-2016·Announced 2016-05-18

Siemens ADVIA Chemistry Triglycerides Reagent Recalled for Interference

Siemens Healthcare Diagnostics is recalling ADVIA Chemistry Triglycerides reagents because N-Acetylcysteine and Metamizole can cause falsely depressed test results.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II. The hazard involves diagnostic interference leading to inaccurate results rather than direct physical injury or contamination, fitting the criteria for moderate severity.

Plain-English summary

Siemens Healthcare Diagnostics, Inc. is recalling ADVIA CHEMISTRY TRIGLYCERIDES_2 (TRIG_2) REAGENT and ADVIA CHEMISTRY TRIGLYCERIDES_2 Concentrated (TRIG_c) REAGENT. The recall involves 13,742 units distributed nationwide to various states and territories. The products are identified by Device Listing D126071 (Catalog # 74082) and D211156 (Catalog # 74084).

The recall was initiated because Siemens confirmed that N-Acetylcysteine (NAC) and Metamizole (Dipyrone) can interfere with Trinder and Trinder-like reaction assays. This interference may result in falsely depressed triglyceride test results for patients receiving these medications. NAC is noted as the accepted antidote for acetaminophen toxicity.

Healthcare facilities and laboratories should stop using the affected reagents and contact Siemens Healthcare Diagnostics for instructions on returning the product or obtaining replacements.

The recalled product

Product
ADVIA CHEMISTRY TRIGLYCERIDES_2 (TRIG_2) REAGENT & ADVIA CHEMISTRY TRIGLYCERIDES_2 Concentrated (TRIG_c) REAGENT
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 (5)

  • Device Listing: D126071
  • Triglyceride_2
  • Catalog # 74082 Device Listing: D211156
  • Triglyceride Concentrated
  • Catalog # 74084

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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