Class 2 Device Recall

• Date Initiated by Firm: March 30, 2006
• Date Posted: May 18, 2006
• Recall Status: Terminated 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: 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