Z-3028-2020 Class II Terminated
FDA device recall Z-3028-2020 was initiated by Beckman Coulter Inc. on August 18, 2020 and is designated Class II. 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. The recall status is terminated (terminated September 8, 2021). Affected quantity: 219 units.
Recall Details
- Product Type
- Devices
- Report Date
- October 7, 2020
- Initiation Date
- August 18, 2020
- Termination Date
- September 8, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 219 units
Product Description
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.
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.
Distribution Pattern
Worldwide distribution - US Nationwide distribution including in the states of CA, FL and NJ. The countries of Algeria, Egypt, Philippines and Taiwan.
Code Information
LOT 2690; Expiration date 10/01/2021