Class 2 Device Recall Remel Thayer Martin Agar (Improved)

• Date Initiated by Firm: October 02, 2003
• Date Posted: October 24, 2003
• Recall Status: Terminated on February 25, 2004
• Recall Number: Z-0069-04
• Recall Event ID: 27473
• Product Classification: Culture Media, For Isolation Of Pathogenic Neisseria - Product Code JTY
• Product: Remel Thayer Martin Agar (Improved), packaged in 10-packs (Cat. #01884), 15-packs (Cat. #01885), and 100 per case (Cat. #01886). The responsible firm on the label is Remel, Lenexa, KS.
• Code Information: 10 pack - Lot #384341, Exp. 11/03/2003; 15 pack - Lot #384342, Exp. 11/3/2003; 100/cs - Lot #384343
• FEI Number: 1924669
• Recalling Firm/ Manufacturer: Remel, Inc; 12076 Santa Fe Trail Dr; Lenexa KS 66215-3519
• For Additional Information Contact: Robert Booth; 913-895-4007
• Manufacturer Reason for Recall: Some of the product lots exhibit no growth of quality control strains of Neisseria gonorrhoeae
• FDA Determined Cause: Other
• Action: The recalling firm initiated recall via letter dated 10/2/03 issued regular mail requesting the customer destroy remaining inventory of the affected lot numbers.
• Quantity in Commerce: 404/10-pks; 67/15-pks; and 33/100-pkg. cases
• Distribution: Distribution was made nationwide to facilities with medical laboratories, including military and government facilities.
• 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.