The FDA today cleared the Cepheid Xpert MTB/RIF Assay to help physicians determine if patients with suspected tuberculosis (TB) can be removed from airborne infection isolation. This expanded use allows healthcare providers to use one or two negative Xpert MTB/RIF Assay test results to help them determine whether a patient showing signs and symptoms of pulmonary TB should continue to be kept in a hospital airborne isolation room.
Category Archives: Food Safety News
Kent, WA Firm Issues Allergy Alert on Undeclared Soy and Egg Allergens in Small Heart Strawberry Tray with Devonshire Dip
Real Foods in Kent, WA is initiating a voluntary recall of 356 cases (712 units) of Small Heart Strawberry Tray with Devonshire Dip, due to misbranding and undeclared allergens. The company was alerted to the issue by a retail operation selling the product, that the strawberry trays were incorrectly packaged with Buttermilk Ranch Dressing in place of Devonshire Dip.
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Hines Nut Company, Dallas, TX Announces Voluntary Recall of Walnut Halves and Pieces Due to Possible Health Risk
Hines Nut Company, Dallas, TX, today announced a voluntary recall of WALNUT HALVES & PIECES, Lot Number 6908. The product was sold by GOLD STATE NUT COMPANY of Biggs, CA, and packaged by Hines Nut Company.
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Hines Nut Company, Dallas, TX Announces Voluntary Recall of Walnut Halves and Pieces Due to Possible Health Risk
Hines Nut Company, Dallas, TX, today announced a voluntary recall of WALNUT HALVES & PIECES, Lot Number 6908. The product was sold by GOLD STATE NUT COMPANY of Biggs, CA, and packaged by Hines Nut Company.
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FDA clears system to reduce stroke risk during stent and angioplasty procedures
The U.S. Food and Drug Administration today cleared for marketing the ENROUTE Transcarotid Neuroprotection System (ENROUTE TNS), for use during a minimally invasive procedure to restore normal blood flow to narrowed carotid arteries. It is the first device designed to access the carotid arteries through an incision in the neck, instead of the groin, and uses a blood flow reversal system to capture pieces of the blockage dislodged during the procedure.
FDA approves Lucentis to treat diabetic retinopathy in patients with diabetic macular edema
The U.S. Food and Drug Administration today expanded the approved use for Lucentis (ranibizumab injection) 0.3 mg to treat diabetic retinopathy (DR) in patients with diabetic macular edema (DME).
Middle East Bakery, Inc. Expands Allergy Alert Due to the Potential for Undeclared Soy in Select Lots of Joseph’s Bread Products and Trader Joe’s Pita Products
Middle East Bakery, Inc. of Lawrence, Massachusetts is recalling select lots of bread products bearing the Joseph’s and Trader Joe’s brand names because they may contain undeclared soy. People who have an allergy or severe sensitivity to soy run the risk of serious or life-threatening allergic reaction if they consume these products.
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Federal judge approves consent decree with Maquet Holding B.V. & Co.
A federal judge from the U.S. District Court for the District of New Hampshire has entered a consent decree of permanent injunction against Maquet Holding B.V. & Co. KG (Maquet), and two of the company’s officers, Heinz Jacqui and Gail Christie, for repeatedly failing to correct violations at three of its companies, which are also named on the consent decree: Atrium Medical Corporation (Atrium) in Hudson, New Hampshire; Maquet Cardiovascular, LLC (Maquet CV) in Wayne, New Jersey; and Maquet Cardiopulmonary AG (Maquet CP) in Rastatt and Hechingen, Germany.
FDA approves first tissue adhesive for internal use
The U.S. Food and Drug Administration (FDA) today approved TissuGlu, the first tissue adhesive approved for internal use.
FDA approves Ibrance for postmenopausal women with advanced breast cancer
The U.S. Food and Drug Administration today granted accelerated approval to Ibrance (palbociclib) to treat advanced (metastatic) breast cancer.