Recall Z-3028-2020— Beckman Coulter Inc.

Name: FDA recall Z-3028-2020
Creator: U.S. Food and Drug Administration
Published: 2020-08-18

Class II · Terminated

Class II FDA medical device recall by Beckman Coulter Inc., initiated 2020-08-18, terminated 2021-09-08. It names one FDA 510(k) clearance: K041793. 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.. 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..

Recalling firm: Beckman Coulter Inc.
Classification: Class II
Status: Terminated
Initiated: 2020-08-18
Terminated: 2021-09-08
Firm location: Brea, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K041793 — OLYMPUS UNSATURATED IRON BINDING CAPCITY REAGENT, OSR6124/0SR6524Olympus America, Inc.·cleared 2004-07-16

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.