Home / Recalls / Medical Devices
bioMerieux, Inc. recalls bioMerieux VITEK 2 Gram Positive Cefoxitin Screen, VITEK 2 Gram Positive AST for Oxacillin, VITEK SYSTEMS General Suscep
Recalled August 29, 2018 · FDA recall Z-2817-2018 · bioMerieux
Hazard
Customer reports indicated an increase in the rate of non-detected MRSA in association with the VITEK 2 AST-P631 product. · FDA Class I
Units
13,961,320 US
Sold at
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.
Description
Customer reports indicated an increase in the rate of non-detected MRSA in association with the VITEK 2 AST-P631 product.
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.
Manufacturer(s)
bioMerieux, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →