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Recall Observatory FDA recall evidence

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

August 18, 2020

Class II

Product summary

Firm
Beckman Coulter Inc.
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

    reason.no_named_rule · v1.0.0

    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.