Olympus Uric Acid Reagent, Model OSR6X98

• • Terminated Z-0211-2020 FDA Class II ·initiated 24 Aug 2018

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

• • Terminated Z-1932-2016 FDA Class II ·initiated 13 Apr 2016

  Beckman Coulter has identified that Dipyrone (Metamizole) may cause erroneous, false low results in the following assays: Cholesterol OSR6X16, Triglyceride OSR6X118, Uric Acid OSR6X98, Lactate OSR6X93, and Lipase OSR6X30.

• • Terminated Z-1024-2015 FDA Class II ·initiated 15 Dec 2014

  N-Acetyl Cysteine (NAC), when administered in therapeutic concentrations for the treatment of acetaminophen overdose, interferes with the assays for these analytes: Cholesterol OSR6X16, Uric Acid OSR6X98, Lactate OSR6X93, and Lipase OSR6X30. NAC interference may lead to falsely low results.

510(k) Number

K062862 ↗

FDA Product Code

KNK

Device Class

Class I

Regulation

21 CFR Part 862.1775

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

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