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FDA allows marketing of first test to identify certain bacteria associated with bloodstream infections

The U.S. Food and Drug Administration today allowed marketing of the first nucleic acid test that can identify 12 different bacterial types known to cause bloodstream infections. The test allows for simultaneous identification of the bacteria and three associated resistance genes in just a few hours after the first sign of bacterial growth. Traditional methods may require two to four days to produce bacterial identification and resistance results.

FDA approves first glaucoma stent for use with cataract surgery

Today, the iStent Trabecular Micro-Bypass Stent System, Model GTS100R/L, was approved by the U.S. Food and Drug Administration. This is the first device approved for use in combination with cataract surgery to reduce pressure inside the eye (intraocular pressure) in adult patients with mild or moderate open-angle glaucoma and a cataract who are currently being treated with medication to reduce intraocular pressure.

Dole Fresh Vegetables Announces Precautionary Recall of Limited Number of Salads, June 22, 2012

Dole Fresh Vegetables is voluntarily recalling 1,077 cases of bagged salads. The products being recalled are Kroger Fresh Selections Greener Supreme coded N158 211B 1613 KR04 with Use-by date of June 19 and UPC 11110 91039, Kroger Fresh Selections Leafy Romaine coded N158 111B KR11 with Use-by date of June 19 and UPC 11110 91046 and Wal Mart Marketside Leafy Romaine coded N158111B with Use-by date of June19 and UPC code 81131 02781 due to a possible health risk from Listeria monocytogenes. Dole Fresh Vegetables is coordinating closely with regulatory officials.

Healthy Choice Recalls All Sizes of Liquid Gold Carrot Juice Including 128oz, 64oz, 32oz, and 16oz Because of Possible Health Risk

Healthy Choice Island Blends, Inc. of Los Angeles, CA, is recalling all sizes of LIQUID GOLD CARROT JUICE including 128oz, 64oz, 32oz, and 16 oz, because it has the potential to be contaminated with Clostridium botulinum, which can cause botulism, a serious and potentially fatal foodborne illness.

Foodborne botulism is a severe type of food poisoning caused by the ingestion of foods containing the potent neurotoxin formed during growth of the organism.

Euphoria Fancy Food Inc Issues an Alert on Uneviscerated Fish

Euphoria Fancy Food Inc. at 149-151 2nd Ave. Brooklyn NY 11215 is recalling DRIED BREAM discovered by New York State Department of Agriculture and Markets Food Inspectors during a routine inspection and subsequent analysis of product by Food Laboratory personnel confirming that the fish was not properly eviscerated prior to processing.

This product may be contaminated with Clostridium botulinum spores, which can cause Botulism, a serious and potentially fatal food-borne illness.

Nidek Medical Products, Inc. issues an Urgent Medical Device Correction affecting oxygen concentrators

Nidek Medical Products, Inc., today announced that the U.S. Food and Drug Administration (FDA) has classified Nidek’s voluntary recall action regarding capacitor-related fires in Medical Mark5 Nuvo Lite Oxygen concentrators as a Class I recall. The affected devices were manufactured and distributed from January 2004 through May 2010 with serial numbers in the range of 042-10000 through 102-09335.