The U.S. Food and Drug Administration today cleared a new screening test that predicts a patient’s risk of future coronary heart disease (CHD) events, such as heart attacks.
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FDA clears test that helps predict the risk of coronary heart disease
The U.S. Food and Drug Administration today cleared a new screening test that predicts a patient’s risk of future coronary heart disease (CHD) events, such as heart attacks.
Baxter Voluntarily Initiates U.S. Recall of Two Lots of Sodium Chloride Injection, USP Due to the Presence of Particulate Matter
Baxter International Inc. announced today it voluntarily initiated a recall in the United States of two lots of 0.9% Sodium Chloride Injection USP in 100 mL MINI-BAG PLUS Container to the hospital/user level. The recall is being initiated as a result of two complaints (one per lot) of particulate matter that was identified as a fragment of the frangible from the vial adapter.
FDA grants CLIA waiver expanding the availability of rapid screening test for syphilis
The U.S. Food and Drug Administration today announced that it granted the first-ever waiver, under certain laboratory regulations, for a rapid screening test for syphilis, which will allow the Syphilis Health Check test to be used in a greater variety of healthcare settings.
FDA grants CLIA waiver expanding the availability of rapid screening test for syphilis
The U.S. Food and Drug Administration today announced that it granted the first-ever waiver, under certain laboratory regulations, for a rapid screening test for syphilis, which will allow the Syphilis Health Check test to be used in a greater variety of healthcare settings.
Flat Creek Farm and Dairy Recalls Cheese Because of Possible Health Risk
Flat Creek Farm & Dairy of Swainsboro, GA has recalled 3 lots of cheese with lot codes 140802XAZ (Aztec Cheddar), 140702XAZ (Low Country Gouda voluntary recall) and 140725XGO (Aztec Cheddar voluntary recall) because of potential to be contaminated with Salmonella. Salmonella is an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems.
FDA expands approved use of Cyramza to treat aggressive non-small cell lung cancer
The U.S. Food and Drug Administration today expanded the approved use of Cyramza (ramucirumab) to treat patients with metastatic non-small cell lung cancer (NSCLC).
Giant Eagle Recalls Apple Pistachio Salad With or Without Chicken Because of Possible Health Risk
Giant Eagle has issued a recall of Giant Eagle Apple Pistachio Salad and Apple Pistachio Salad with Chicken because the salads may contain fresh cut Gala red apples currently recalled by Del Monte Fresh Produce N.A. due to potential Listeria monocytogenes contamination. To date, Giant Eagle has received no reports of customer illnesses associated with this recall.
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RZM Food Factory to cease operations for repeated food safety violations
William H. Oshiro, owner of RZM Food Factory, has agreed to stop processing and distributing food until he demonstrates to the FDA that RZM Food Factory’s facility and practices comply with federal food safety requirements. The agreement, known as a consent decree of permanent injunction, was signed by a federal judge and entered in the U.S. District Court of Hawaii on Dec. 12, 2014.
FDA approves first test to confirm the presence of Human T-cell Lymphotropic Virus-I/II antibodies
The U.S. Food and Drug Administration today approved MP Diagnostics HTLV Blot 2.4, the first FDA-licensed supplemental test for Human T-cell Lymphotropic Virus-I/II (HTLV-I/II). This test is intended for use as an additional, more specific test for human serum or plasma specimens that have previously tested positive on an FDA-licensed HTLV-I/II blood donor screening test. The MP Diagnostics HTLV Blot 2.4 is a qualitative enzyme immunoassay test intended to confirm infection with HTLV and to differentiate between HTLV-I and HTLV-II.