Devices

Remel Recalls Thermo Scientific Sensititre Plates

Remel is recalling (Class 1) Thermo Scientific Gram Negative IVD AST Sensititre Plates due to the risk of potential false susceptible results for Proteae Tribe (including Proteus spp., Providencia spp., Morganella Morganii) when tested with the following antibiotics: Carbapenem (doripenem, ertapenem, meropenem, imipenem), cefepime, piperacillin/tazobactam, and aztreonam.

The in vitro diagnostic is used for clinical susceptibility testing of non-fastidious Gram-negative organisms, comprising enterobacterales, Pseudomonas aeruginosa, and other non-enterobacteriaceae, according to a recall notice. The test results may indicate that treatment with these antibiotics will stop or slow the growth of Proteae Tribe bacteria when that may not be accurate, it says. “A false susceptibility result could lead patients to receive an ineffective treatment and experience serious injury or health consequences, including increased time in the hospital, unnecessary tests or procedures, treatment failure, sepsis, and even death,” it adds.

Remel, the U.S. agent and part of Thermo Fisher Scientific, is investigating the root cause and will implement corrective actions to prevent future recurrence, the notice says.

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