UIBC — Class II medical device recall Z-3028-2020
Terminated recall by Beckman Coulter Inc., reported 2020-10-07, distributed nationwide. The manufacturer has identified that the use of Unsaturated Iron Binding Capacity (UBIC) lot 2690 will produce
| Recall number | Z-3028-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Beckman Coulter Inc., Brea, CA, United States |
| Recall initiated | 2020-08-18 |
| Classified | 2020-09-30 |
| Reported by FDA | 2020-10-07 |
| Terminated | 2021-09-08 |
| Distributed | Nationwide (US) |
| Countries outside the US | DZ, EG, PH, TW |
| Quantity | 219 units |
| UPC / GTIN / UDI-DI | 15099590011925 |
| Lot numbers | 2690 |
| Model numbers | OSR61205 |
| Expiration dates | 2021-10-01 |
Product
UIBC; Catalog Number: OSR61205; UDI (01) 15099590011925; IVD; Rx Only; WARNING H316 H317 H351 H373 H411 - Product Usage: System reagent for the quantitative determination of Unsaturated Iron Binding Capacity (UIBC) in human serum and plasma on Beckman Coulter AU analyzers.
Reason for recall
The manufacturer has identified that the use of Unsaturated Iron Binding Capacity (UBIC) lot 2690 will produce erroneously high patient results at the low end of the linear range.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-3028-2020. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.