Agency classClass IIOur severity:Moderate FDA (Devices)·Z-2079-2017·Announced 2017-05-24

Beckman Coulter Recalls Uric Acid Reagent Due to Drug Interference

Beckman Coulter is recalling Uric Acid Reagent because certain drugs can cause false low results. The recall covers 100,286 units distributed worldwide.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

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 involves potential false low results due to drug interference rather than direct physical injury or contamination, fitting the criteria for a moderate severity recall.

Plain-English summary

Beckman Coulter Inc. is recalling Uric Acid Reagent (URIC 2 x 300), Catalog No. 442785, which is intended for the quantitative determination of uric acid concentration in human serum, plasma, or urine. The recall was initiated because the company identified specific drugs as potential sources of interference that may result in false low results.

The affected drugs include Metamizole (Dipyrone), Sulfasalazine, and Sulfapyridine. A total of 100,286 units are involved in the recall, with 20,732 units distributed in the United States. The product was distributed worldwide to numerous countries, including the United States, Canada, and various nations in Europe, Asia, and the Middle East.

Healthcare facilities and laboratories should stop using the affected reagent and contact Beckman Coulter for further instructions on handling the product. Users should be aware that the presence of the identified drugs in patient samples may lead to inaccurate test results.

The recalled product

Product: Uric Acid Reagent (URIC 2 x 300), Catalog No. 442785. Intended for the quantitative determination of uric acid concentration in human serum, plasma or urine.
Manufacturer: Beckman Coulter Inc.
Category: Medical Device — In Vitro Diagnostic Reagent
Hazard: false-low-results
drug-interference

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 in 1 state:

Part of a larger recall action

This product is one of 7 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 7 products in this recall →

Same manufacturer · Beckman Coulter Inc.

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