Recall Z-3028-2020
Beckman Coulter Inc. · initiated August 18, 2020
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
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.
Codes / lots: LOT 2690; Expiration date 10/01/2021
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.
FDA-determined cause: Under Investigation by firm
Action taken
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.
Details
- Recall number
- Z-3028-2020
- Initiated
- August 18, 2020
- Terminated
- September 8, 2021
- Product code
- JMO – Ferrozine (Colorimetric) Iron Binding Capacity
- 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.
- Recalling firm
- Beckman Coulter Inc., Brea, CA