Devices

FDA Continues Warning About Magellan Diagnostics Test

FDA says that based on studies conducted by Becton Dickinson (BD), it continues to recommend that Magellan Diagnostics lead tests not be used with blood samples taken from the vein. A statement by CDRH Office of In Vitro Diagnostics and Radiological Health acting director Donald St. Pierre says that Magellan’s lead test systems can continued to be used with blood samples from a finger or heel stick.

The agency first warned in 5/2017 that the Magellan tests may provide inaccurate results for some children and adults in the U.S.

At FDA’s request, BD, which manufactures certain blood sample collection tubes often used with many lead tests, studied the accuracy of Magellan’s LeadCare testing systems when used with vein blood collected into BD tubes. The statement says the tests showed there was a significant chance of false results with Magellan’s LeadCare tests when used with whole blood collected from the vein and stored in certain BD tubes.

“Upon further investigation,” St. Pierre says, “BD determined that the affected tubes’ rubber stoppers contain a chemical called thiuram that can release sulfur-containing gases that dissolve into blood samples and bind tightly to lead particles. This chemical reaction makes it difficult for the Magellan lead tests to detect the correct amount of lead in a sample.”

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