Recall Z-2264-2025

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 taken

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.