Class 2 Device Recall UIBC Reagent

• Date Initiated by Firm: June 26, 2025
• Date Posted: August 04, 2025
• Recall Status: Open, Classified
• Recall Number: Z-2264-2025
• Recall Event ID: 97178
• 510(K)Number: K041793
• Product Classification: Ferrozine (colorimetric) iron binding capacity - Product Code JMO
• Product: UIBC (Unsaturated Iron Binding Capacity), REF: OSR61205,
• Code Information: All Lots/(01)15099590011925
• Recalling Firm/ Manufacturer: Beckman Coulter Inc.; 250 S Kraemer Blvd; Brea CA 92821-6232
• For Additional Information Contact: Marguerita Sweeney; 714-961-5321
• Manufacturer 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.
• FDA Determined Cause: Process design
• Action: 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.
• Quantity in Commerce: 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.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = JMO