Recalls / —
—#183255
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.
- FDA product code
- JMO — Ferrozine (Colorimetric) Iron Binding Capacity
- Device class
- Class 1
- Medical specialty
- Clinical Chemistry
- 510(k) numbers
- K041793
- Affected lot / code info
- LOT 2690; Expiration date 10/01/2021
Why it was recalled
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 (FDA determination)
Under Investigation by firm
Action the firm took
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.
Recalling firm
- Firm
- Beckman Coulter Inc.
- Address
- 250 S Kraemer Blvd, Brea, California 92821-6232
Distribution
- Distribution pattern
- Worldwide distribution - US Nationwide distribution including in the states of CA, FL and NJ. The countries of Algeria, Egypt, Philippines and Taiwan.
Timeline
- Recall initiated
- 2020-08-18
- Terminated
- 2021-09-08
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #183255. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.