Recall Z-0211-2020— Beckman Coulter Inc.

Name: FDA recall Z-0211-2020
Creator: U.S. Food and Drug Administration
Published: 2018-08-24

Class II · Terminated

Class II FDA medical device recall by Beckman Coulter Inc., initiated 2018-08-24, terminated 2024-08-02. It names one FDA 510(k) clearance: K062862. Product: Beckman Coulter Uric Acid, REF OSR6098, OSR6198, and OSR6698.. Reason: NAPQI, a metabolite of Acetominophen, causes negative interference with the recalled product assays at levels present in the serum/plasma of overdose patients..

Recalling firm: Beckman Coulter Inc.
Classification: Class II
Status: Terminated
Initiated: 2018-08-24
Terminated: 2024-08-02
Firm location: Brea, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K062862 — OLYMPUS URIC ACID REAGENT, MODEL OSR6X98Olympus America, Inc.·cleared 2007-04-06

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.