Olympus Unsaturated Iron Binding Capcity Reagent, OSR6124/0SR6524

• • Ongoing Z-2264-2025 FDA Class II ·initiated 26 Jun 2025

  Beckman Coulter identified that the Unsaturated Iron Binding Capacity (UIBC) assay is not meeting their labeled hemoglobin interference claims of no significant interference (i.e., less than 10%) up to 200 mg/dL hemoglobin as indicated in their instructions for use. Initial internal testing confirmed that samples with low UIBC levels failed the claimed hemolysis interference specifications with reported biases up to -43.6 % UIBC when hemolyzed serum samples contained 200 mg/dL hemoglobin.

• • Terminated Z-3028-2020 FDA Class II ·initiated 18 Aug 2020

  The manufacturer has identified that the use of Unsaturated Iron Binding Capacity (UBIC) lot 2690 will produce erroneously high patient results at the low end of the linear range.

510(k) Number

K041793 ↗

FDA Product Code

JMO

Device Class

Class I

Regulation

21 CFR Part 862.1415

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

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