"Bringing the BD Veritor™ At-Home COVID-19 Test to Amazon.com enables U.S. consumers to purchase and perform an at-home COVID-19 test without leaving the comfort of their own home," said Dave Hickey, president of Life Sciences for BD.
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.
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.
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 Libertas Wearable 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.
This funding will enable RetiSpec to accelerate the commercialization of its groundbreaking technology aimed at early detection of Alzheimer's disease.