Devices

Beckman Coulter Cytometer Recall is Class 1

FDA says a Beckman Coulter recall of its FC 500 and EPICS XL series flow cytometers is Class 1. An agency recall notice says the devices are used to simultaneously analyze multiple characteristics of thousands of individual cells in a relatively short period of time. They can be used to diagnose and monitor conditions, like blood cancers, and other blood disorders, and for immune monitoring in HIV patients and other immunocompromised patients.

Beckman Coulter says it recalled the devices due to an electrical circuit error that may cause the device amplifier board to malfunction and produce inaccurate results. The issue has the potential to affect all tests run on the cytometers for any application, including laboratory-developed tests, FDA says.

While no patient injuries have been reported to date, the agency notice says that the use of an affected product may cause serious, life-threatening adverse health consequences such as misdiagnosis and improper patient management and treatment for several blood conditions and diseases.

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome