10/14/21 -- Abbott Molecular, Inc. is recalling Alinity m SARS-CoV-2 AMP Kits and Alinity m Resp-4-Plex AMP Kits because they have the potential to give false positive results when used to detect SARS-CoV-2. Read the FDA recall notice.
10/14/21 -- The CDC is inviting partners to join in observing U.S. Antibiotic Awareness Week (USAAW) November 18-24, 2021 to help spread the word about the importance of appropriate antibiotic use to effectively treat infections, protect patients, and combat antibiotic resistance.
10/13/21 -- The FDA continues to monitor the risk of Nontuberculous mycobacteria (NTM) infections in patients who have undergone cardiothoracic surgery using heater-cooler devices, and to collaborate with stakeholders including public health partners, manufacturers, and experts to evaluate additional strategies to reduce the risk of infection from using these devices during cardiothoracic surgery.
10/12/21 -- The FDA announced that it intends to withdraw, effective Dec. 31, 2021, guidances originally issued in March 2020 outlining temporary policies for manufacturers that were not drug manufacturers at the time to produce certain alcohol-based hand sanitizer and alcohol for use in hand sanitizers during the public health emergency.
10/12/21 -- The FDA is alerting test users, caregivers, healthcare personnel, and the public of the potential for false positive results with certain lots of the Ellume COVID-19 Home Test, due to a recently identified manufacturing issue. Negative results do not appear to be affected by the manufacturing issue. The FDA is working closely with Ellume to assess the company’s additional manufacturing checks and other corrective steps to help ensure that the issue is resolved. Read the FDA safety alert.
9/28/21 -- The FDA issued a warning letter to Strategia Project Management, Inc. for selling an unapproved product with unproven COVID-19 claims. The company sells non-alcohol-based topical antiseptics via the internet and social media that make unproven claims to mitigate, prevent, treat, diagnose, or cure COVID-19 and other serious infections in people.
10/8/21 -- The FDA announced updates to improve regulatory oversight of surgical staplers and staples. The agency issued a final order reclassifying surgical staplers for internal use from Class I (general controls) to Class II (special controls) and requiring them to undergo premarket review. As a result, surgical staplers for internal use will be subject to more stringent regulatory requirements, including requiring premarket notification and special controls to help mitigate known risks of the device.
10/5/21 -- The FDA is urging consumers to stop using artnaturals hand sanitizer products due to unacceptable levels of benzene, acetaldehyde, and acetal contaminants. Read the FDA safety alert.
10/4/21 -- The FDA issued an emergency use authorization (EUA) for the ACON Laboratories Flowflex COVID-19 Home Test, an over-the-counter (OTC) COVID-19 antigen test, which adds to the growing list of tests that can be used at home without a prescription. Read the FDA announcement.
9/30/21 -- Influenza immunization in the pediatric population is particularly important during the severe COVID-19 pandemic. Hear from experts from the American Academy of Pediatrics and the CDC on strategies to improve prevention and control of influenza among children this season. The webinar is Thursday, October 7, 2 -3 PM ET. Free continuing education is available. Click here for more information or to access the webinar.