Devices

Quidel Lyra Covid Assay Recall for False Negative Risk is Class 1: FDA

FDA says a Quidel 4/26 recall of specified lots of its Lyra SARS-CoV-2 assay due to a significant risk of false-negative results for patients with relatively high amounts of SARS-CoV-2 virus potentially causing the PCR (polymerase chain reaction) amplification to occur before a cycle-threshold value of ≥ 5 when using specified thermocyclers is Class 1. An agency notice says the lots were manufactured between 3/17/20 and 3/12/21 and distributed between 3/17/20 and 5/27/21. The firm’s recall covers 18,385 kits that each contain 96 reactions.

“False-negative results may lead to delayed diagnosis or inappropriate treatment of SARS-CoV-2 that may cause patient harm, serious illness, and death,” FDA says. “False-negative results can also lead to further spread of the SARS-CoV-2 virus when presumed negative patients are introduced into groups within healthcare, long-term care, or other similar facilities. Actions to limit exposure based on false-negative results might not be taken, such as isolating infected individuals.”

The agency says Quidel has received five complaints about the assay, with no reports of injuries or deaths associated with the issue.

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