Official recall record

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

US FDA — Medical Devices · 2025-06-26 · United StatesClass II

Issuing authority: US FDA — Medical Devices
Recall initiated by firm: 2025-06-26
Country of alert: United States
Alert level: Class II
Alert type: recall
Barcode (EAN/GTIN): 15099590011925
Brand on record: Beckman Coulter Inc.
Product category: Medical Device

What the authority reported

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.

What to do

Follow the instructions in the official notice — recall remedies (refund, repair, replacement, or disposal) are defined by the issuing authority and the responsible business, and they differ per recall. Do not rely on summaries, including this one.

Verify at the source: US FDA — Medical Devices — official record →
Record last checked against the registry on 2026-05-31.

More recalls: US FDA — Medical Devices · United States · all filters

Same barcode in other registries

The same EAN appears in 1 other official recall record(s) — a cross-border signal worth checking if you bought this product abroad.

2020-08-18 · US FDA — Medical Devices
UIBC; Catalog Number: OSR61205; UDI (01) 15099590011925; IVD; Rx Only; WARNING H316 H317 H351 H373 H411 - Product Usage:

Other recalls from this brand

2026-09-02 · US FDA — Medical Devices
DxC 500i Clinical Analyzer Modules: 1. DxC 500 AU Module w/ISE, DxC 500i, Part No. C63522 2. DxC 500 AU
2026-09-02 · US FDA — Medical Devices
DxC 500 AU Clinical Chemistry Analyzers: 1. AU w/out ISE, Part No. C63519 2. AU w/ISE, Part No. C63520
2026-07-15 · US FDA — Medical Devices
Beckman Coulter DxC 500i Clinical Analyzer Modules using software version 1.5 or lower: 1) DxC 500 AU Modul

All 32 official recall notices naming Beckman Coulter, Inc. on this site →

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