Class 3 Device Recall VersaTREK Myco AS.

• Date Initiated by Firm: August 08, 2005
• Date Posted: September 14, 2005
• Recall Status: Terminated on July 21, 2007
• Recall Number: Z-1540-05
• Recall Event ID: 33135
• Product Classification: System, Blood Culturing - Product Code MDB
• Product: VersaTREK Myco AS.
• Code Information: lot code 144365, expiration date 2005/11.
• Recalling Firm/ Manufacturer: Trek Diagnostic Systems; 982 Keynote Cir Ste 6; Cleveland OH 44131-1873
• For Additional Information Contact: Teresa Anacker; 800-642-7029
• Manufacturer Reason for Recall: Invitro diagnostic test kit used for testing to confirm the presence of tuberculosis contains interfering bioburden which can cause false positive results.
• FDA Determined Cause: Other
• Action: The recalling firm phoned all 13 consignees that the product was distributed to, and sent a recall letter to all 13 consignees, dated August 8, 2005. All 13 consignees have responded back to the recalling firm and have discarded any remaining product that was on hand.
• Quantity in Commerce: 29 boxes containing 5 vials in each box.
• Distribution: The product was distributed to consignees located in AL, IA, IL, MD, NJ, OH, PA, Washington D.C. and to two foreign distributors: I.L. Diagnostics, Lago Victoria No. 80, Col. Granada, Mexico D.F., 11520; and Trivitron Diagnostics, #15 4th Street, Abhiramapuram, Chennai, India 600-018.
• 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.