Beckman Coulter Inc. recalls Beckman Coulter Uric Acid, REF OSR6098, OSR6198, and OSR6698.

Recall date

August 24, 2018

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0211-2020

FDA classification

Class II

Brand / firm

Beckman Coulter Inc.

Sold / distributed

Distribution was nationwide. There was government and military distribution. Foreign distribution was made to Canada.

Why it was recalled

NAPQI, a metabolite of Acetominophen, causes negative interference with the recalled product assays at levels present in the serum/plasma of overdose patients.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Beckman Coulter Uric Acid, REF OSR6098, OSR6198, and OSR6698.