# FDA recall Z-3028-2020

> **Beckman Coulter Inc.** · Class II · device recall initiated 2020-08-18.

## 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.

## Distribution

Worldwide distribution - US Nationwide distribution including in the states of CA, FL and NJ. The countries of Algeria, Egypt,  Philippines and Taiwan.

## Key facts

- **Recall number:** Z-3028-2020
- **Recalling firm:** Beckman Coulter Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2020-08-18
- **Report date:** 2020-10-07
- **Termination date:** 2021-09-08

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Brea, CA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3028-2020

## Citation

> AI Analytics. FDA recall Z-3028-2020. Retrieved 2026-06-12 from https://api.ai-analytics.org/recall/Z-3028-2020. Source: US FDA. Licensed CC0.

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