Class 3 Device Recall BioPlex 2200 Syphilis IgG Kit

• Date Initiated by Firm: September 25, 2007
• Date Posted: November 09, 2007
• Recall Status: Terminated on April 16, 2008
• Recall Number: Z-0256-2008
• Recall Event ID: 45332
• 510(K)Number: K063866
• Product Classification: Syphilis IgG Kit - Product Code LIP
• Product: BioPlex 2200 System, Cat. No. 665-1460A containing APF CD SW2_v1., Syphilis IgG IFU Packet contains the Syphilis IgG Assay Protocol File LAPF CD
• Code Information: Cat. No. 665-1460A containing APF CD SW2_v1.
• Recalling Firm/ Manufacturer: Bio-Rad Labroatories Inc.; 4000 Alfred Noble Dr.; Hercules CA 94547
• For Additional Information Contact: 510-741-7000
• Manufacturer Reason for Recall: Mislabeling: Reporting terminology in the Syphilis IgG APF CD is not consistent with the distributed Instructions for Use. (Non-Reactive and Reactive rather than Negative and Positive)
• FDA Determined Cause: Labeling Change Control
• Action: The recalling firm notified consignees by phone call on 9/25/2007, followed up with a fax notification. The firm plans to monitor the consignees that do not respond by tracking on a spreadsheet and following up with another phone call. Consignees are instructed to destroy the APF CD which will be replaced at a later date.
• Quantity in Commerce: 36
• Distribution: Nationwide
• 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 = LIP and Original Applicant = Bio-Rad Laboratories