Recall Z-2264-2025 ยท JMO Ferrozine (Colorimetric) Iron Binding Capacity
Beckman Coulter Inc.
UIBC (Unsaturated Iron Binding Capacity), REF: OSR61205,
| Date | Aug 4, 2025 (initiated Jun 26, 2025) |
| Status | Open, Classified |
| Reason | 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 | 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, u |
| Quantity | 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, Hun |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K041793 | OLYMPUS UNSATURATED IRON BINDING CAPCITY REAGENT, OSR6124/0SR6524 Olympus America, Inc., Jul 16, 2004 |