Class 3 Device Recall BHI Agar

• Date Initiated by Firm: June 27, 2006
• Date Posted: August 29, 2006
• Recall Status: Terminated on June 14, 2011
• Recall Number: Z-1451-06
• Recall Event ID: 36048
• 510(K)Number: K964560
• Product Classification: Agar - Product Code JSO
• Product: BHI Agar with Vancomycin, for in vitro diagnostic use. Catalog # G14, Lot# 06136
• Code Information: Lot# 06136
• Recalling Firm/ Manufacturer: Hardy Media Inc Dba Hardy Diag; 1430 W Mccoy Ln; Santa Maria CA 93455-1005
• For Additional Information Contact: Kelley J. Day; 805-346-2766 Ext. 5695
• Manufacturer Reason for Recall: This recall is being conducted due to the performance failure nearing the end of the product shelf life.
• FDA Determined Cause: Other
• Action: Customers were first notified by phone on 6/28/06, then all customers were faxed and mailed a signed recall letter via first class mail.
• Quantity in Commerce: 860 plates
• Distribution: Nationwide in AZ, CA, IA, ID, MI, MT, NC, & WY. Plus: Puerto Rico
• 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 = JSO