Recall Z-3028-2020 ยท JMO Ferrozine (Colorimetric) Iron Binding Capacity
Beckman Coulter Inc.
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.
| Date | Aug 18, 2020 |
| Status | Terminated |
| 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. |
| Root cause | Under Investigation by 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. |
| Quantity | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K041793 | OLYMPUS UNSATURATED IRON BINDING CAPCITY REAGENT, OSR6124/0SR6524 Olympus America, Inc., Jul 16, 2004 |