Class 3 Device Recall

• Date Initiated by Firm: December 31, 2003
• Date Posted: February 24, 2004
• Recall Status: Terminated on May 17, 2004
• Recall Number: Z-0542-04
• Recall Event ID: 28120
• Product Classification: Discs, Strips And Reagents, Microorganism Differentiation - Product Code JTO
• Product: Nitrate Reagent A, Cat No. Z71, Lot 3338; Nitrate Reagent B, Cat No. A72, Lot 3338
• Code Information: Lot 3338.
• 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
• Manufacturer Reason for Recall: Mislabeled.
• FDA Determined Cause: Other
• Action: Customers were first notified by telephone on 12/31/2003. Then customers are mailed a sigh\ned recall letter via first class mail. All customers will be contacted by telephone to reconcile returns.
• Quantity in Commerce: 39 bottles of Z71 and 6 bottles of Z72
• Distribution: TX, CA, ID, Puerto Rico, KS, WY,
• 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.