Devices

Celltrion Covid Test Recall is Class 1

FDA says a Celltrion USA 2/28 recall of its Celltrion DiaTrust Covid-19 Ag Rapid Test is Class 1. Some 45,500 units that were distributed between 6/2 and 12/21/21 were recalled due to a high number of false-positive reports for some tests, an agency statement says. Also, FDA says, the tests’ labeling includes a shelf life of 18 months but the agency’s emergency use authorization specifies the test may only be used for 12 months.

“Although there have been no reports of injuries, adverse health consequences or death associated with the use of the test,” FDA says, “false positive or false negative results from improper use of these tests could lead to further exposure of uninfected individuals to SARS-CoV-2 virus. There are also serious injury risks if someone who is not trained to collect a nasopharyngeal swab sample attempts to do so.”

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