Recall Z-2264-2025— Beckman Coulter Inc.

Name: FDA recall Z-2264-2025
Creator: U.S. Food and Drug Administration
Published: 2025-06-26

Class II · Ongoing

Class II FDA medical device recall by Beckman Coulter Inc., initiated 2025-06-26. It names one FDA 510(k) clearance: K041793. Product: UIBC (Unsaturated Iron Binding Capacity), REF: OSR61205,. Reason: 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..

Recalling firm: Beckman Coulter Inc.
Classification: Class II
Status: Ongoing
Initiated: 2025-06-26
Firm location: Brea, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K041793 — OLYMPUS UNSATURATED IRON BINDING CAPCITY REAGENT, OSR6124/0SR6524Olympus America, Inc.·cleared 2004-07-16

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

UIBC (Unsaturated Iron Binding Capacity), REF: OSR61205,

Reason for recall

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.

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