Summary
The FDA issued a Class II for UIBC (Unsaturated Iron Binding Capacity), REF: OSR61205, by Beckman Coulter Inc.. Reason: Beckman Coulter identified that the Unsaturated Iron Binding Capacity (UIBC) assay is not meeting their labeled hemoglobin interference claims of no s.
Details
Source
Device Recall
External ID
Z-2264-2025
Action Date
2025-08-13
Status
Ongoing
Category
device
Product Description
UIBC (Unsaturated Iron Binding Capacity), REF: OSR61205,
Lot/Code Info: All Lots/(01)15099590011925
Quantity Affected: 56,696 units
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.
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.
Type: Voluntary: Firm initiated
Recall Initiated: 2025-06-26
Company
Brea, CA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 172 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Beckman Coulter Inc. has 158 FDA actions in our database, including 111 recalls and 47 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Beckman Coulter Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Beckman Coulter Inc. have FDA actions?
Beckman Coulter Inc. has 158 FDA actions in our database, including 111 recalls and 47 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2264-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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