BioMerieux VITEK Positive Cefoxitin Screen recalled over mold contamination

Recall date

January 26, 2018

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

bioMerieux, Inc. recalls bioMerieux VITEK 2 Gram Positive Cefoxitin Screen, VITEK 2 Gram Positive AST for Oxacillin, VITEK SYSTEMS General Susce…

Recall number

Z-2817-2018

FDA classification

Class I

Brand / firm

bioMerieux, Inc.

Sold / distributed

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…

Why it was recalled

Customer reports indicated an increase in the rate of non-detected MRSA in association with the VITEK 2 AST-P631 product.

Class I is the FDA’s most serious recall level: there is a reasonable probability that using this product will cause serious harm or death.

What was recalled

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.