The FDA granted marketing authorization of the Cobas vivoDx MRSA (Methicillin-resistant Staphylococcus aureus) test to Roche Molecular Systems Inc. The new diagnostic test based on bacterial viability and novel technology and allows faster evaluation of patients for colonization with MRSA bacteria. The authorization adds a new tool in the fight to prevent and control MRSA in high-risk settings. The Cobas vivoDx MRSA test uses a new bacteriophage technology based on bioluminescence to detect MRSA from nasal swab samples in as little as 5 hours compared to 24-48 hours for conventional culture. the Cobas vivoDx MRSA test correctly identified MRSA in approximately 90% of samples where MRSA was present and correctly identified no MRSA in 98.6% of samples that did not have MRSA present. This action also creates a new regulatory classification, which means that subsequent devices of the same type with the same intended use may go through the FDA’s 510(k) pathway, whereby devices can obtain clearance by demonstrating substantial equivalence to a predicate device. @ https://www.fda.gov/news-events/press-announcements/fda-authorizes-marketing-diagnostic-test-uses-novel-technology-detect-mrsa-bacteria?utm_campaign=120519_PR_FDA%20authorizes%20novel%20MRSA%20test&utm_medium=email&utm_source=Eloqua
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FDA authorized a new diagnostic test to detect MRSA bacterial colonization, a widespread cause of hospital-acquired infections.
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According to the CDC, as of December 2, 2019, 102 people from 23 states were infected with the outbreak strain of E. coli O157:H7. The case patients report that illnesses started on dates ranging from September 24, 2019, to November 18, 2019. Illness onset dates reported to date are before the public warning issued on November 22. FDA continues to investigate the cause of this outbreak. Samples and information collected as part of farm investigations are currently being analyzed. The FDA and state partners are conducting a traceback investigation to determine whether a common supplier or source of contamination can be identified. The Salinas region includes Santa Cruz, Santa Clara, San Benito, and Monterey counties in California. @ https://www.fda.gov/food/outbreaks-foodborne-illness/investigation-e-coli-o157h7-outbreak-linked-romaine-salinas-california-november-2019?utm_campaign=Outbreak%20E.%20coli%20Romaine%2012042019&utm_medium=email&utm_source=Eloqua
FDA continues to warn against eating romaine from Salinas, investigate farms, conduct traceback
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The Canadian Food Inspection Agency (CFIA) announced that Loblaw Companies Ltd. recalls President’s Choice brand Coleslaw from the marketplace due to possible Salmonella contamination.
This recall was triggered by CFIA due to positive Salmonella test results. The recalled product was distributed in Alberta, British Columbia, Manitoba, Ontario, and possibly nationally and n Saskatchewan. No reported illnesses have been associated with the consumption of the recalled product. @ https://www.inspection.gc.ca/about-the-cfia/newsroom/food-recall-warnings/complete-listing/2019-12-03/eng/1575413977507/1575413982486?utm_source=r_listserv
Loblaw Companies Ltd. is recalling President’s Choice brand Coleslaw from the marketplace due to possible Salmonella contamination. Consumers should not consume the recalled product described below.
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The FDA announced that Fuji Food Products, Inc. (Fuji) voluntary recall of ready to eat sushi, salads and spring rolls sold to select retailers and distributors along the East Coast and Upper Midwest, due to potential Listeria monocytogenes contamination. No reported any illness associated with these products. The problem was discovered in their Brockton Massachusetts facility by a routine inspection conducted by the FDA. The company has ceased production and distribution of its products in this facility. The products are packed in plastic trays with clear lids, and the sell-by dates are on the labels. The products were sold and/or distributed in the following states Alabama, Connecticut, Delaware, Florida, Georgia, Illinois, Indiana, Iowa, Kansas, Kentucky, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Nebraska, New Hampshire, New Jersey, New York, North Carolina, Ohio, Pennsylvania, Rhode Island, South Carolina, Tennessee, Vermont, Virginia, Washington D.C., West Virginia, and Wisconsin The products were sold at 7 Eleven, Walgreens, Food Lion, Hannaford, Trader Joe’s, Giant Eagle Supermarkets, Porkys, Bozzutos, Supreme Lobster and Superior Foods. @ https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/fuji-food-products-inc-voluntarily-recalls-ready-eat-sushi-salads-and-spring-rolls-manufactured-east
Fuji Food Products, Inc. (Fuji) announced today the voluntary recall of ready to eat sushi, salads and spring rolls sold to select retailers and distributors along the East Coast and Upper Midwest.