Beckman Coulter Inc. 2025-08-13 Health serious FDA
Health · FDA · Recall #FDA-Z-2264-2025
UIBC (Unsaturated Iron Binding Capacity), REF: OSR61205, Recall
Issued August 13, 2025 · Beckman Coulter Inc.
In August 2025, Beckman Coulter Inc. recalled the UIBC (Unsaturated Iron Binding Capacity), REF: OSR61205,, a serious health recall reported by the FDA.
Compiled by Maya Ellison, RecallCheckr
What this means for you
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 you should do
- 1 Stop using UIBC (Unsaturated Iron Binding Capacity), REF: OSR61205, right away.
- 2 Set it aside where it won't be used by mistake.
- 3 Contact Beckman Coulter Inc. to arrange your voluntary. See the official notice below for contact details.
- 4 Keep the product until your remedy is fully processed. You may need it.
Official remedy (Voluntary):
Recall details
- Brand
- Beckman Coulter Inc.
- Category
- Health
- Recall date
- August 13, 2025
- Units affected
- Not reported
- Sold at
- US: AK, AL, AR, CO, CT, DC, DE, ID, UT OUS: Algeria, Argentina, Australia, Bahrain, Bangladesh, Belarus, Belgium, Bosnia and Herzegovina, B
- Recall number
- FDA-Z-2264-2025
- Made in
- United States
- Issuing agency
- FDA
In context
- Beckman Coulter Inc. has 4 recalls in our database.
- We're tracking 3,576 Health recalls in our database.
- This is the 691st Health recall we've logged in 2025.