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.
Reported: October 7, 2020 Initiated: August 18, 2020 #Z-3028-2020
Product Description
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.
Details
- Recalling Firm
- Beckman Coulter Inc.
- Units Affected
- 219 units
- Distribution
- Worldwide distribution - US Nationwide distribution including in the states of CA, FL and NJ. The countries of Algeria, Egypt, Philippines and Taiwan.
- Location
- Brea, CA
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Beckman Coulter Inc.. Units affected: 219 units.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on October 7, 2020. Severity: Moderate. Recall number: Z-3028-2020.
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