Class 1 Device Recall VITEK 2 Gram Negative Susceptibility Card, ASTN087

• Date Initiated by Firm: September 16, 2010
• Date Posted: November 11, 2010
• Recall Status: Terminated on May 08, 2012
• Recall Number: Z-0197-2011
• Recall Event ID: 56760
• 510(K)Number: K080107
• Product Classification: System, test, automated, antimicrobial susceptibility, short incubation - Product Code LON
• Product: VITEK 2 Gram Negative Susceptibility Card, AST-N087, REF 22 235, For In Vitro Diagnostic Use, 20 cards/box. The firm names on the label are bioMerieux, Inc., Durham, NC, and bioMerieux sa, 69280 Marcy-l'Etoile France.
• Code Information: All lot numbers
• Recalling Firm/ Manufacturer: Biomerieux Inc; 595 Anglum Rd; Hazelwood MO 63042
• For Additional Information Contact: Lisa Bezzole; 314-731-8667
• Manufacturer Reason for Recall: AMENDED REASON FOR RECALL: The piperacillin/tazobactam drug on the antimicrobial susceptibility cards is providing false susceptible and false resistant results for E. coli, as well as an additional 7 organisms; and the same drug is providing false resistant results for K. pneumoniae.
• FDA Determined Cause: Nonconforming Material/Component
• Action: bioMerieux issued a "Product Correction Notice" letter dated September 13, 2010, to their entire customer base (regardless of whether they ever ordered the recalled cards). The letters explained the reason for the recall and instructed the account to confirm all results for E. coli using a second method, and for K. pneumoniae, to confirm with a second method only for resistant results. These alternate test confirmations are to continue until further notice. The customers were to complete and return the enclosed Acknowledgement Form via fax at (314) 731-8689 or (919) 620-6350 which indicate that the notice has been read, the instructions provided in the "Actions Required" section were followed, and notes if they have received any reports of illness or injury related to this issue. All future shipments will include an orange multilanguage insert to go into the boxes reminding customers they must perform an alternate test for TZP/E. coli combinations and that customers must also perform an alternate method prior to reporting TZP results when a resistant result is obtained for the TZP/K. pneumoniae. Additionally, this recall letter will accompany shipments of instrument software kits for the new customers. The recalling firm issued a press release on 10/27/10 via the Associated Press notifying the public of the recall. The recalling firm expanded their recall to add 7 more organisms to the list of organism testing that were to be suppressed. As a result the recalling firm issued a letter dated 3/30/11 via Fed Ex on 4/4/11 flagged "URGENT PRODUCT CORRECTION NOTICE (EXPANDED RECALL), VITEK 2 Piperacillin/Tazobactam Test, Document #9300786." The letter describes the issues, how the issues impact the test results, describes the product changes that are going to take place, and provides instructions on required actions to be taken. The product changes will involve the eventual changeover to new cards that will be created which do not contain Piperacillin/Taz
• Quantity in Commerce: 9,399 boxes as of 3/8/11
• Distribution: Worldwide Distribution: USA (all states), and the countries of: SUBSIDIARIES - Argentina, Canada, Switzerland, Chile, Colombia, Germany, Spain, Great Britain, Hong Kong, Japan, Korea, Mexico, Poland, Brazil, Sweden, Singapore, and Thailand. DISTRIBUTORS - Dutch Antilles, Australia, Bermuda, Uruguay, Costa Rica, Dominican Republic, Ecuador, France, Guatemala, Honduras, Indonesia, Israel, Italy, Singapore, Malaysia, Nicaragua, The Netherlands, Panama, Peru, Philipines, Paraguay, El Salvador, Venice, and Viet Nam.
• 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 = LON