The Recall Desk
ModerateFDA (Devices)·Z-1932-2016·Announced 2016-06-15

Beckman Coulter Uric Acid Reagent Recalled for False Low Results

Beckman Coulter is recalling Uric Acid reagent (OSR6x98) because Dipyrone may cause erroneous, false low results in 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. The hazard is a diagnostic error (false low results) rather than a direct physical injury or contamination, fitting the criteria for moderate severity involving potential adverse health consequences through misdiagnosis.

Plain-English summary

Beckman Coulter Inc. is recalling Uric Acid, Catalog No. OSR6x98, a system reagent intended for the quantitative determination of uric acid in human serum, heparinized plasma, and urine on Beckman Coulter AU analyzers. The recall affects all lots of the product.

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

A total of 59,401 units were distributed worldwide, with 10,868 units distributed in the United States, including Puerto Rico. The product was also distributed to numerous countries across the globe. Users of the product should be aware that Dipyrone may interfere with the accuracy of the test results.

The recalled product

Product
Uric Acid, Catalog No. OSR6x98 Product Usage:Uric acid OSR6x98 is intended as a System reagent for the quantitative determination of Uric Acid in human serum, heparinized plasma and urine 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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