The Recall Desk
ModerateFDA (Devices)·Z-1933-2016·Announced 2016-06-15

Beckman Coulter Cholesterol Reagent Recalled for False Low Results

Beckman Coulter is recalling Cholesterol OSR6x16 reagent because Dipyrone may cause erroneous, false low results in cholesterol assays.

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, but the hazard is a diagnostic error (false low results) rather than a direct physical injury or contamination, fitting the criteria for a moderate severity precautionary recall.

Plain-English summary

Beckman Coulter Inc. is recalling Cholesterol, Catalog No. OSR6x16, a system reagent intended for the quantitative determination of cholesterol concentrations in human serum on Beckman Coulter AU analyzers. The recall affects 43,877 units total, including 10,496 units in the US, distributed worldwide.

The recall was initiated because Beckman Coulter identified that Dipyrone (Metamizole) may cause erroneous, false low results in the Cholesterol OSR6X16 assay. This issue is part of a broader identification affecting several other assays, including Triglyceride, Uric Acid, Lactate, and Lipase.

Healthcare facilities and laboratories using this reagent should stop using the affected product and contact Beckman Coulter for instructions on how to proceed. The recall covers all lots of the product.

The recalled product

Product
Cholesterol, Catalog No. OSR6x16 Product Usage:Cholesterol OSR6x16 is intended as a System reagent for the quantitative determination of Cholesterol concentrations in human serum on Beckman Coulter AU analyzers.
Manufacturer
Beckman Coulter Inc.
Category
Medical Device — Laboratory Reagent
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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Same manufacturer · Beckman Coulter Inc.

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Same hazard · diagnostic error

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