Devices

Warning Letter to Kabe Follows Recent Safety Alert

FDA has issued a Warning Letter to Kabe Labortechnik, the North Rhine-Westphaia, Germany-based manufacturer of the RAM Scientific SAFE-T-FILL Capillary Collection System tubes distributed by ASP Global that are linked to a safety alert issued last month on reports of falsely elevated (false positive) results that have occurred when using the tubes with LeadCare Testing Systems. “These tests may overestimate blood lead levels and give inaccurate results when processing capillary blood samples collected in these ASP Global’s RAM Scientific SAFE-T-FILL tubes,” an agency notice says. Because the root cause is not yet known, FDA is recommending that the tubes not be used with the LeadCare Testing Systems while the issue is being investigated.

The Warning Letter says FDA inspected the firm earlier this year and documented GMP deficiencies. For example, the agency says the firm has not validated the manufacturing process the blood collection tubes. Kabe also failed to adequately ensure that all equipment used in the manufacturing process meets specified requirements and is appropriately designed, constructed, placed, and installed to facilitate maintenance, adjustment, and cleaning, the letter says. Additionally, the inspection found that written Medical Device Reporting procedures do not exist.

The letter noted that because of the serious nature of the violations, all devices manufactured by the firm will be refused entry into the U.S. until the violations are corrected.

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

Read more

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