The Recall Desk
ModerateFDA (Devices)·Z-1934-2016·Announced 2016-06-15

Beckman Coulter Recalls Triglyceride Assay Due to Dipyrone Interference

Beckman Coulter is recalling Triglyceride OSR6x118 assays because Dipyrone may cause false low 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 potential diagnostic errors (false low results) due to chemical interference, which is a significant quality issue but does not involve direct physical injury or acute toxicity, fitting the Moderate category for labeling/quality defects without reported harm.

Plain-English summary

Beckman Coulter Inc. is recalling the Triglyceride OSR6x118 assay, a product intended for the quantitative determination of triglyceride in human serum and plasma on Beckman Coulter AU analyzers. The recall affects 79,009 units total, including 21,215 units in the United States.

The recall was initiated because Beckman Coulter identified that Dipyrone (Metamizole) may cause erroneous, false low results in the Triglyceride OSR6x118 assay. The source text notes that this interference issue also affects other assays, including Cholesterol OSR6X16, Uric Acid OSR6X98, Lactate OSR6X93, and Lipase OSR6X30.

The product was distributed worldwide, including the United States (nationwide including Puerto Rico) and numerous other countries. The recall covers all lots of the affected product. Users should stop using the product and contact Beckman Coulter for further instructions.

The recalled product

Product
Triglyceride, Catalog No. OSR6x118 Product Usage:Triglyceride OSR6x118 is intended as an Enzymatic colour test for the quantitative determination of triglyceride in human serum and plasma on Beckman Coulter AU analyzers.
Manufacturer
Beckman Coulter Inc.
Category
Medical Device — In Vitro Diagnostic
Hazard

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)

  • All lots

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Part of a larger recall action

This product is one of 5 recalled by Beckman Coulter 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 5 products in this recall →

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