—#214735

Product

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

FDA product code: JMO — Ferrozine (Colorimetric) Iron Binding Capacity
Device class: Class 1
Medical specialty: Clinical Chemistry
510(k) numbers: K041793
Affected lot / code info: All Lots/(01)15099590011925

Why it was 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.

Root cause (FDA determination)

Process design

Action the firm took

On July 10, 2025, Beckman Coulter issued a "Urgent Medical Device Recall" via mail and E-Mail to affected consignees. Beckman Coulter asked consignees to take the following action: 1. Sharing the content of this letter with your laboratory and/or Medical Director to evaluate the requirement for a retrospective review of UIBC results for hemolysed samples. 2. Discontinuance or disposal of this product is not necessary. 3. Per the IFU, avoid hemolysed samples when using the UIBC assay. 4. If the LIH influence check setting for hemolysis has been enabled on AU/DxC AU instruments for UIBC, update the setting per the instructions in the letter. 5. Please share this information with your laboratory staff and retain this notification as part of your laboratory Quality System documentation. 6. If you have forwarded any of the affected product listed above to another laboratory, please provide them a copy of this letter. 7. So that we are assured you have received this important communication, please respond within 10 days in one of the following ways: Electronically, if you received this communication via email or manually, complete and return the enclosed Response Form.

Recalling firm

Firm: Beckman Coulter Inc.
Address: 250 S Kraemer Blvd, Brea, California 92821-6232

Distribution

Distribution pattern: 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.

Timeline

Recall initiated: 2025-06-26
Posted by FDA: 2025-08-04
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #214735. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.