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.
Take action
Contact the company
📍Recalling firmBeckman Coulter Inc.250 S Kraemer Blvd · Brea, CA 92821-6232
“Beckman Coulter UIBC Assay May Not Meet Hemoglobin Interference Claims.” GovInfoNow, updated August 10, 2026. https://govinfonow.com/recall/51957-beckman-coulter-uibc-assay-may-not-meet-hemoglobin-interference-claims. Based on FDA recall #Z-2264-2025 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2264-2025%22&limit=1).
The FDA announced on June 26, 2025, that Beckman Coulter, Inc. is recalling UIBC (Unsaturated Iron Binding Capacity) assay kits due to inaccurate test results. The company said the product fails to meet labeled hemoglobin interference claims.
How to tell if you have it
Brand: Beckman Coulter
Product: UIBC (Unsaturated Iron Binding Capacity)
Reference: OSR61205
UPC: 15099590011925
Lot code: (01)15099590011925
Units affected: 56,696
The hazard
Beckman Coulter identified that the assay is not meeting labeled hemoglobin interference claims of no significant interference up to 200 mg/dL. Initial internal testing confirmed samples with low UIBC levels failed claimed hemolysis interference specifications, with reported biases up to -43.6% UIBC when hemolyzed serum samples contained 200 mg/dL hemoglobin.
Context
GovInfoNow's records show Beckman Coulter, Inc. has 132 other recalls on record since June 20, 2017. Recent recalls include the DxC 500 AU Modules with Software 1.5 (July 15, 2026), MicroScan LabPro V5.03 Panel Update 11 (June 26, 2026), and Access Total T4 Calibrator (March 16, 2026). Other recent recalls of similar products include the Bicarbonate Reagent (October 14, 2025), LDL Cholesterol Reagent (December 8, 2025), and Emit 2000 Quinidine Assay (July 13, 2026).
How to tell if you have this one
Check for the product name 'UIBC (Unsaturated Iron Binding Capacity)' with lot number (01)15099590011925. The recall covers all lots of this product.
Brand
Beckman Coul: Inc.
Product
Beckman Coulter Inc. recalls UIBC (Unsaturated Iron Binding Capacity), REF: OSR61205
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Product Lot
Look for the lot number (01)15099590011925 on the UIBC assay kit packaging.
Where it went and when
Where it was distributed
Distributed in 8 states and D.C. and Puerto Rico, and outside the U.S.
Listed by the agency
Not listed
FDA 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,…” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: Alabama, Alaska, Arkansas, Colorado, Connecticut, Delaware, District of Columbia, Idaho, Puerto Rico, Utah.
Recall timeline
FDA published this recall 48 days after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-2264-2025 (June 26, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2264-2025 to see it in context.
Plain-language summary written by qwen3:4b on August 10, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.