Reported Oct 7, 2020 · Terminated
UIBC; Catalog Number: OSR61205; UDI (01) 15099590011925; IVD; Rx Only; WARNING H316 H317 H351 H373 H411 - Product…
Beckman Coulter Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Beckman Coulter Inc. · 250 S Kraemer Blvd · Brea, CA · 92821-6232
Is this the product you have?
6 of 6 products
| Model / number | Barcodes | Product as published |
|---|---|---|
| — | UIBC | |
OSR61205 | — | |
| — | 15099590011925 | 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. |
- Lot codes and dates
LOT 2690Expiration date 10/01/2021
- Amount recalled
- 219 units
Where it was sold
Why it was 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.
This product could cause temporary or reversible health problems — stop using it.
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