Class 1 Device Recall VITEK 2 Gram Positive Cefoxitin Screen,VITEK 2 Gram Positive AST for Oxacillin

• Date Initiated by Firm: January 26, 2018
• Date Posted: August 30, 2018
• Recall Status: Terminated on May 20, 2019
• Recall Number: Z-2817-2018
• Recall Event ID: 80619
• 510(K)Number: K053097
• Product Classification: System, test, automated, antimicrobial susceptibility, short incubation - Product Code LON
• Product: bioMerieux VITEK 2 Gram Positive Cefoxitin Screen, VITEK 2 Gram Positive AST for Oxacillin, VITEK SYSTEMS General Susceptibility Card Cefotoxin and AST for Oxacillin bioMerieux VITEK 2 AST-P631 bioMerieux VITEK 2 AST-GP67 Test Kit bioMerieux VITEK 2 AST-GP71 Test Kit bioMerieux VITEK 2 AST-GP75 Test Kit bioMerieux VITEK 2 AST-GP78 Test Kit Components for an automated invitro diagnostic system consisting of instruments, software and reagent cards designed for the ID and antimicrobial susceptibility testing of bacteria and yeast.
• Code Information: VITEK 2 AST-P631, Ref # 414961 UDI 03573026426804 OXSF, multiple Gram Positive Cards all lots of cards with Oxacillin and Cefotoxin OX, OXSF, multiple Gram Positive Cards all lots of cards with Oxacillin and Cefotoxin VITEK 2 AST-GP67 Test Kit, Ref: # 22226 UDI 03573026242060, OX, OXSF, multiple Gram Positive Cards, all lots of cards with Oxacillin and Cefotoxin. VITEK 2 AST-GP71 Test Kit, Ref: #410750 UDI 03573026355173, OX, OXSF, multiple Gram Positive Cards, all lots of cards with Oxacillin and Cefotoxin. VITEK 2 AST-GP75 Test Kit, Ref: #415670 UDI 03573026437183, OX, OXSF, multiple Gram Positive Cards, all lots of cards with Oxacillin and Cefotoxin. VITEK 2 AST-GP78 Test Kit, Ref: #421051 UDI 03573026553982, OX, OXSF, multiple Gram Positive Cards, all lots of cards with Oxacillin and Cefotoxin.
• Recalling Firm/ Manufacturer: bioMerieux, Inc.; 100 Rodolphe St; Durham NC 27712-9402
• For Additional Information Contact: Clinical Customer Support Representative; 919-620-2000
• Manufacturer Reason for Recall: Customer reports indicated an increase in the rate of non-detected MRSA in association with the VITEK 2 AST-P631 product.
• FDA Determined Cause: Under Investigation by firm
• Action: bioMerieux sent an Urgent Product Correction Notice letter to their French customers on January 26, 2018. Customer letters in the Americas were sent August 21, 2018. The letters identified the affected product, problem, and actions to be taken. Customers should follow steps outlined in the letter and contact bioMerieux for any additional questions regarding these corrective actions. Note: the actions do not include removal of the product. For any questions or concerns, contact your local bioMerieux representative.
• Quantity in Commerce: 13,961,320 US
• Distribution: Worldwide distribution. US nationwide including Puerto Rico, Bermuda, Brazil, Canada, China, Curacao, Costa Rica, Dominican Republic, Ecuador, France, Guatemala, Indonesia, Israel, Hong Kong, South Korea, South Africa, Mexico, Myanmar, Nicaragua, Peru, Philippines, Paraguay, Singapore, Thailand, El Salvador, and Vietnam.
• 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