Class 2 Device Recall VITEK GPS106 Gram Positive Susceptibility Card

• Date Initiated by Firm: January 15, 2004
• Date Posted: July 20, 2004
• Recall Status: Terminated on November 24, 2004
• Recall Number: Z-0725-04
• Recall Event ID: 28429
• Product Classification: System, Test, Automated, Antimicrobial Susceptibility, Short Incubation - Product Code LON
• Product: VITEK GPS-106 Gram Positive Susceptibility Card, Catalog #V4335, for in-vitro diagnostic use, 20 cards per package. The responsible firm on the label is bioMerieux, Inc., Durham, NC and bioMerieux sa, France.
• Code Information: Lot P61X, Exp. 5/12/05
• Recalling Firm/ Manufacturer: bioMerieux Inc; 595 Anglum Rd; Hazelwood MO 63042-2320
• For Additional Information Contact: Nancy Weaver; 314-731-8595
• Manufacturer Reason for Recall: The cards were stamped with an incorrect card code that causes the system to read and analyze the cards incorrectly.
• FDA Determined Cause: Other
• Action: The firm issued recall letters dated 1/15/04 via regular mail requesting remaining inventories be destroyed and explaining the method which the customer can use to confirm the cards were not misreported. The firm also issued a 'Second Notification' recall letter dated 3/9/04.
• Quantity in Commerce: 1,955/20-card boxes
• Distribution: Distribution was nationwide to medical facilities, including V.A. and military customers. There was no foreign distribution.
• 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.