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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 March 30, 2006
Date Posted May 18, 2006
Recall Status1 Terminated 3 on February 29, 2012
Recall Number Z-0886-06
Recall Event ID 35258
510(K)Number K013076  
Product Classification Radioimmunoassay, Vancomycin - Product Code LEH
Product SYNCHRON Systems Vancomycin Reagent, in vitro diagnostic. Part Number 474824.
Code Information Lot numbers M507219 & M511327
Recalling Firm/
Manufacturer		 Beckman Coulter Inc
200 S Kraemer Blvd
Brea CA 92822-6208
For Additional Information Contact Eri H. Hirumi
714-961-4389
Manufacturer Reason
for Recall		 Beckman Coulter has received reports of patient samples and quality control recovery shifting low when using Vancomycin reagent lots M507219 and M511327. Internal QC recovery was as much as 15% lower than the assigned target value.
FDA Determined
Cause 2		 Other
Action A Product Corrective Action (PCA) letter was be sent the week of MAR 30, 2006 to all SYNCHRON Systems Vancomycin Reagent customers of lot numbers M507219 and M511327 informing them to discontinue use and discard reagent. (Letters were sent by US mail)
Quantity in Commerce 3147
Distribution Nationwide & 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 = LEH and Original Applicant = BECKMAN COULTER, INC.
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