Device 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.
Z-3028-2020
Product summary
- Event
- Event 86273
- Status
- Terminated
- Classification
- Class II
- Quantity
- 219 units
- Official record key
device-enforcement:Z-3028-2020
Official wording
Reason: 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.
Code information: LOT 2690; Expiration date 10/01/2021
Distribution pattern: Worldwide distribution - US Nationwide distribution including in the states of CA, FL and NJ. The countries of Algeria, Egypt, Philippines and Taiwan.
Derived failure modes
-
Unknown
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.