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U.S. Department of Health and Human Services

Class 2 Device Recall Unsaturated Iron Binding Capacity

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  Class 2 Device Recall Unsaturated Iron Binding Capacity see related information
Date Initiated by Firm August 18, 2020
Create Date September 30, 2020
Recall Status1 Terminated 3 on September 08, 2021
Recall Number Z-3028-2020
Recall Event ID 86273
510(K)Number K041793  
Product Classification Ferrozine (colorimetric) iron binding capacity - Product Code JMO
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.
Code Information LOT 2690; Expiration date 10/01/2021
Recalling Firm/
Manufacturer		 Beckman Coulter Inc.
250 S Kraemer Blvd
Brea CA 92821-6232
For Additional Information Contact Marguerita Sweeney
714-961-5321
Manufacturer 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 2		 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 in Commerce 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = JMO and Original Applicant = OLYMPUS AMERICA, INC.
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