PlainRecalls
FDA Devices Moderate Class II Ongoing

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

Reported: August 13, 2025 Initiated: June 26, 2025 #Z-2264-2025

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.

Details

Recalling Firm
Beckman Coulter Inc.
Units Affected
56,696 units
Distribution
US: AK, AL, AR, CO, CT, DC, DE, ID, UT OUS: Algeria, Argentina, Australia, Bahrain, Bangladesh, Belarus, Belgium, Bosnia and Herzegovina, Brazil, Bulgaria, Canada, China, Colombia, Costa Rica, Croatia, Czechia, Egypt, El Salvador, Ethiopia, Georgia, Germany, Ghana, Gibraltar, Greece, Hong Kong, Hungary, India, Indonesia, Ireland, Israel, Italy, Jordan, Kazakhstan, Korea, Republic of, Kuwait, Lebanon, Libya, Lithuania, Malaysia, Maldives, Mexico, Morocco, Mozambique, Myanmar, Nepal, Netherlands, Nigeria, North Macedonia, Oman, Pakistan, Panama, Peru, Philippines, Poland, Portugal, Puerto Rico, Qatar, Romania, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, Somalia, South Africa, Spain, Sri Lanka, Sweden, Taiwan, Province of China, Thailand, Tunisia, Turkey, United Arab Emirates, United Kingdom of Great Britain and Northern Ireland, Uzbekistan, Viet Nam, Yemen.
Location
Brea, CA

Frequently Asked Questions

What product was recalled? ▼
UIBC (Unsaturated Iron Binding Capacity), REF: OSR61205,. Recalled by Beckman Coulter Inc.. Units affected: 56,696 units.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on August 13, 2025. Severity: Moderate. Recall number: Z-2264-2025.

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