Devices

BASE10 Genetics Kit Recall is Class 1: FDA

FDA says the 1/20 recall by BASE10 Genetics of its RNAstill MTM specimen collection kits is Class 1. The company is recalling the kits because they were distributed without proper premarket clearance from FDA. An agency notice says there are not enough data available about the product to know how well it inactivates and stabilizes a virus for transport and storage.

The company recalled 455,791 units that were distributed to nursing homes, assisted living facilities, and memory facilities whose residents are at high risk of severe illness and death from Covid-19 between 9/16/20 and 12/1/21. The kits are intended for collection, transport, inactivation, stabilization, and long-term storage of nasopharyngeal or oropharyngeal swab samples without dry ice, refrigeration, or special containment.

FDA says if a sample is not properly inactivated and stabilized by the transport medium there are two concerns:

if the sample deteriorates, it could lead to false negative results; and
if the virus isn’t inactivated before testing, it could spread to people in the lab.

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