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U.S. Department of Health and Human Services

Class 2 Device Recall

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  Class 2 Device Recall see related information
Date Initiated by Firm February 23, 2005
Date Posted March 08, 2005
Recall Status1 Terminated 3 on September 02, 2005
Recall Number Z-0576-05
Recall Event ID 31253
510(K)Number k925802  
Product Classification Enzyme Immunoassay, Digoxin - Product Code KXT
Product Access Immunoasay Systems Digoxin Reagent
Code Information Lots 323171; 416110; 417703; 419534
Recalling Firm/
Beckman Coulter Inc
200 S Kraemer Blvd
Brea CA 92822-6208
For Additional Information Contact Kathleen Jaker
Manufacturer Reason
for Recall
Variability in results on Patient and QC results of 20-25%, high and low.
FDA Determined
Cause 2
Action Letters were sent to customers via UPS overnite, they request that alternative methods be used for patient testing until new material is made available. Customers are requested to ask for replacements using a fax back form.
Quantity in Commerce 4352 domestically.
Distribution Nationwide and Canada
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 = KXT and Original Applicant = BIO-RAD LABORATORIES, INC.