Class 2 Device Recall ADVIA 1650 Chemistry System

• Date Initiated by Firm: September 08, 2006
• Date Posted: January 17, 2007
• Recall Status: Terminated on May 23, 2012
• Recall Number: Z-0352-2007
• Recall Event ID: 36713
• 510(K)Number: K990346
• Product Classification: in vitro diagnostic - Product Code LEG
• Product: ADVIA 1650 Chemistry System, Automated Clinical Chemistry Analyzer - human serum, plasma and urine tests. The following are the measured parameters that are within the scope of this ''field correction'': Affected assay: Valproic Acid. Affecting assays: Digoxin; Phenytoin; Gentamicin; Theophylline.
• Code Information: All ADVIA 1650 Chemistry Systems are involved as well as all existing assay lots for Valproic Acid (VPA), Phenytoin (PHNY), Gentamicin (GENT), Digoxin (DIG), and Theophylline (THEO). ADVIA 1650 Part # 073-A001, VPA Part # B01-4784-01, PHNY Part # B01-4775-01, DIG Part # B01-4769-01, GENT Part # B01-4787-01, THEO Part # B01-4772-01.
• Recalling Firm/ Manufacturer: Bayer Healthcare, LLC (Diagnostics Division); 511 Benedict Avenue; Tarrytown NY 10591-5097
• For Additional Information Contact: Mr. Steven H. Andberg; 508-660-8540
• Manufacturer Reason for Recall: Bayer received a customer complaint where the Valproic Acid Quality control material recovered lower than target when it was run in a panel of other Therapeutic Drug (TDM) assays. The under recovery observed by the customer was approximately -25%. Investigation into this issue was initiated promptly following receipt of this complaint.
• FDA Determined Cause: Software design
• Action: On 9/08/06, a Support Bulletin was sent to all affected Bayer HealthCare LLC Branches in order to inform them of the issue and to provide them with instructions for the 'field correction'. On 9/08/06, a Customer Bulletin was sent to all affected Bayer HealthCare LLC Branches both in the US and worldwide for communication with the affected end user customers. The bulletin advises of the problem and the corrective action. A Completion Confirmation (Fax-back) Form was included to ensure that all customers worldwide have been notified and have complied with the mandatory action. The Customer Bulletin is to be sent to all affected end user customers. Bayer Technical Service Specialists will follow-up with all of the ADVIA Chemistry System customers to make sure they have understood the bulletin and to ask that they return the FAX-back Completion Confirmation Form to Bayer HealthCare. If Bayer HealthCare does not receive the form in a timely manner, specialists in the Bayer Technical Care Center will contact the customer through whatever means possible in an effort to obtain 100% effectiveness on this communication.
• Quantity in Commerce: 1184 instruments total, all products
• Distribution: Worldwide, including USA, Puerto Rico, Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Columbia, Czech Republic, Denmark, Egypt, Finland, France, Germany, Greece, Hong Kong, Hungary, Ireland, Israel, Italy, Korea, Malaysia, Mexico, The Netherlands, New Zealand, Norway, Poland, Portugal, Russia, Serbia, Singapore, Slovakia, South Africa, Spain, Saudi Arabia, Sweden, Switzerland, Syria, Taiwan, Turkey, and United Kingdom.
• 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 = LEG