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U.S. Department of Health and Human Services

Class 3 Device Recall

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  Class 3 Device Recall see related information
Date Initiated by Firm April 01, 2003
Date Posted July 23, 2004
Recall Status1 Terminated 3 on August 30, 2004
Recall Number Z-1151-04
Recall Event ID 29095
510(K)Number K013235  
Product Classification Radioimmunoassay, Vancomycin - Product Code LEH
Product Synchron Liquid Comprehensive Chemistry Control Serum.

Part numbers: 660710, 657365.
Code Information Lots: M202040, M206290
Recalling Firm/
Beckman Coulter Inc
200 S Kraemer Blvd
Brea CA 92822-6208
Manufacturer Reason
for Recall
The quality control samples for Vancomycin would not recover correctly when compared to the S.I. unit values listed in the incorrectly printed product insert. The incorrectly printed values were higher than they should be by a factor of 3 (three).
FDA Determined
Cause 2
Quantity in Commerce 9730
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 = LEH and Original Applicant = BECKMAN COULTER, INC.