Medtech Recall Round-Up: May 2024

This month, companies including Philips Respironics, Abbott, and Masimo were caught in the crosshairs of FDA ire.

Katie Hobbins, Managing Editor

May 29, 2024

7 Slides

BioMérieux Vitek AST Kit

FDA announced that BioMérieux’s recall of the Vitek 2 AST Kit has been identified as Class I. The Vitek 2 AST kit, which includes the Gram-negative Susceptibility Card, is a test used to understand the susceptibility of certain types of bacteria to antibiotics.

BioMérieux recalled the Vitek 2 AST cards, an antimicrobial sensitivity testing kit, due to incorrect concentrations of Ceftriaxone antibiotic in two wells. The two wells have been reported to have more of the antibiotic than designated. Use of the affected kits may cause serious adverse health consequences, according to the company, including increased time in the hospital, unnecessary tests or procedures, treatment failure, sepsis, and death. Of note, this recall is considered a correction, not a product removal. There have been no reports of injuries or deaths associated with the recall.

About the Author(s)

Katie Hobbins

Managing Editor, MD+DI

Katie Hobbins is managing editor for MD+DI and joined the team in July 2022. She boasts multiple previous editorial roles in print and multimedia medical journalism, including dermatology, medical aesthetics, and pediatric medicine. She graduated from Cleveland State University in 2018 with a bachelor's degree in journalism and promotional communications. She enjoys yoga, hand embroidery, and anything DIY. You can reach her at [email protected].

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