BD Announces Assay for Identification of COVID-19 Patients at Increased Relative Risks of Intubation with Mechanical Ventilation, Mortality at Hospital Admission Now Available in Europe
BD announced the CE mark of BD Multitest™ 6-Color TBNK Reagent with BD Trucount™ Tubes with expanded clinical application
FACSLyric Flow Cytometer with Newly Integrated BD FACSDuet™ Sample Preparation System Receives FDA Clearance
The new integrated system enables clinical laboratories to fully automate the sample to answer process and improve their efficiency by reducing errors and limiting the manual user interactions required to run assays on the BD FACSLyric Flow Cytometer.
Three of the situations described in this recall, which BD announced on June 30, 2020, have been designated as Class I recalls by the U.S. Food and Drug Administration (FDA), which means that there is a reasonable probability that the use of the product will cause serious adverse health consequences or death. One of the situations was designated as a Class II recall, which means the use of the product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
CME America Announces a Follow-Up on the Voluntary Recall of BodyGuard® Infusion System Administration Sets
As part of CME America's commitment to quality, following the previously announced recall (April 27, 2020) of the BodyGuard® Infusion Pump Systems, the company conducted additional flow-rate accuracy testing. This testing revealed that some infusion sets do not meet the ±5% delivery accuracy for the system or the ±13% accuracy identified in the earlier recall notification. Therefore, the use of the pump system potentially could cause over-infusion or under-infusion of therapy and patient harm.
The U.S. Food and Drug Administration (FDA) has granted Emergency Use Authorization (EUA) for a new diagnostic test that will enable hospitals to screen for COVID-19 (coronavirus) on site and get results in under three hours.
BD Kiestra™ ReadA provides closed-door incubation and high throughput imaging to streamline workflow, delivering high-quality images for digital interpretation by laboratory staff.
The award-winning injector* is a subcutaneous drug delivery system, currently in development, that is designed to require no patient assembly and deliver biologics with viscosities up to 50 cP in 2-5 mL and 5-10 mL configurations.
BD (Becton, Dickinson and Company) (NYSE: BDX), a leading global medical technology company, today announced the launch of the BD Intevia™ 1mL two-step disposable autoinjector, a robust platform device combining autoinjector and pre-fillable syringe in one integrated...
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