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.
FDA Recall Z-3028-2020 · Posted None
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Recalling FirmBeckman Coulter Inc.
Recall StatusTerminated
Product CodeJMO
Date Initiated2020-08-18
Date Terminated2021-09-08
Product Quantity219 units
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.
Firm Action
An Urgent Medical Device Recall letter was sent on 08/18/2020 to the affected customers via mail and/or email. The customers are advised to discontinue the use of UIBC lot 2690. When available, replace it with an unaffected lot of UIBC.
Root Cause
Under Investigation by firm
Distribution Pattern
Worldwide distribution - US Nationwide distribution including in the states of CA, FL and NJ. The countries of Algeria, Egypt, Philippines and Taiwan.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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