FDA Device recall Z-2264-2025
UIBC (Unsaturated Iron Binding Capacity), REF: OSR61205
- FDA Device
- Class II
- ongoing
- Published 2025-08-13
On 2025-08-13 the FDA classified a Class II recall of UIBC (Unsaturated Iron Binding Capacity), REF: OSR61205 by Beckman Coulter, citing 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.….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2264-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-06-26 |
| Published | 2025-08-13 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Beckman Coulter |
| Distribution | AK, AL, AR, CO, CT, DC, DE, GA, ID, PR, UT |
Product
UIBC (Unsaturated Iron Binding Capacity), REF: OSR61205,
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.
Identifiers
| code_info | All Lots/(01)15099590011925 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2264-2025%22
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