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The CDC has released an alert stating that malaria is a medical emergency and that anyone with symptoms should be urgently evaluated following the identification of locally acquired malaria cases in Florida and Texas within the last two months. In Florida, four cases within close geographic proximity have been identified (Sarasota County), and one case …
E-cigarette makers are adding potentially dangerous levels of the synthetic cooling agents WS-3 and WS-23 to disposable e-cigarettes and e-cigarette refills sold in the U.S., according to research published at the ATS 2022 international conference. Mint and menthol-flavored e-cigarettes are highly popular due to their “cooling” effect. E-cigarette suppliers recently started marketing synthetic cooling agents …
The FDA has issued an alert on September 17, 2021, regarding the potential for false-positive COVID-19 testing results using certain kits manufactured by Abbott Molecular Inc. Letter to Clinical Laboratory Staff and Health Care Providers: The U.S. Food and Drug Administration (FDA) is alerting clinical laboratory staff and health care providers of the potential for …
According to a recent FDA newsletter alert, some consumer electronic devices, such as certain cell phones and smartwatches, include high field strength magnets. Recent studies have shown that consumer electronic devices with high field strength magnets may cause certain implanted medical devices to switch to “magnet mode” and suspend normal operations until the magnet is …
According to the FDA, a “drug is removed from the market when its risks outweigh its benefits. A drug is usually taken off the market because of safety issues with the drug that cannot be corrected, such as when it is discovered that the drug can cause serious side effects that were not known at …
FDA alert: Do not drink, cook with, sell, or serve “Real Water” alkaline water The FDA, along with the CDC and the Southern Nevada Health District is investigating a number of reports of acute non-viral hepatitis in the state of Nevada. On March 13, the FDA was alerted to five cases of acute non-viral hepatitis …
The US FDA is alerting clinical laboratory staff, point-of-care (POC) facility staff, and health care providers that false-positive results can occur with the Roche Molecular Systems, Inc. (Roche) cobas SARS-CoV-2 & Influenza A/B Nucleic Acid Test for use on the cobas Liat System. The false-positive results may be related to two issues observed by Roche. …
According to the FDA salves that contain corrosive ingredients, including “black salve” and a number of other names, are dangerous and can be life-threatening. From the FDA Consumer Update: You may have seen websites selling certain salves or creams (commonly known as “black salve”) claiming to treat or cure cancer, boils, moles and skin tags …
The US FDA has issued a warning letter to Battelle Memorial Institute for failure to comply with regulatory requirements for medical device reporting as specified in the Emergency Use Authorization (EUA) for the Battelle Critical Care Decontamination System. From the press announcement: “It is critical that manufacturers have an effective process in place for reporting …
A new report has recently been published as part of safety surveillance efforts from the FDA on the harmful side effects that are associated with breast implants, including certain cases of cancer as well as what is being termed as “breast implant illness” which is a collection of symptoms that can include but is not …