FDA CDC News
FDA Authorizes First Over-the-Counter At-Home Test to Detect Both Influenza and COVID-19 Viruses
Agency Continues Its Commitment to Increase Availability of Home Diagnostic Tests
Today, the U.S. Food and Drug Administration issued an emergency use authorization (EUA) for the first over-the-counter (OTC) at-home diagnostic test that can differentiate and detect influenza A and B, commonly known as the flu, and SARS-CoV-2, the virus that causes COVID-19. The Lucira COVID-19 & Flu Home Test is a single-use at-home test kit that provides results from self-collected nasal swab samples in roughly 30 minutes.
“Today’s authorization of the first OTC test that can detect Influenza A and B, along with SARS-CoV-2, is a major milestone in bringing greater consumer access to diagnostic tests that can be performed entirely at home,” said Jeff Shuren, M.D., J.D., director of the FDA’s Center for Devices and Radiological Health. “The FDA strongly supports innovation in test development, and we are eager to continue advancing greater access to at-home infectious disease testing to best support public health needs. We remain committed to working with test developers to support the shared goal of getting more accurate and reliable tests to Americans who need them.”
The Lucira COVID-19 & Flu Home Test is a single use test for individuals with signs and symptoms consistent with a respiratory tract infection, including COVID-19. The test can be purchased without a prescription and performed completely at-home using nasal swab samples self-collected by individuals ages 14 years or older or collected by an adult for individuals 2 years of age or older.
The test works by swirling the sample swab in a vial that is placed in the test unit. In 30 minutes or less, the test unit will display the results that show whether a person is positive or negative for each of the following: Influenza A, Influenza B and COVID-19. Individuals should report all results obtained to their healthcare provider for public health reporting and to receive appropriate medical care.
In individuals with symptoms, the Lucira COVID-19 & Flu Home Test correctly identified 99.3% of negative and 90.1% of positive Influenza A samples, 100% of negative and 88.3% of positive COVID-19 samples and 99.9% of negative Influenza B samples. Since there are currently not enough cases of Influenza B circulating to include in a clinical study, validation confirmed that the test can identify the virus in contrived specimens, and the EUA requires Lucira to continue to collect samples to study the test’s ability to detect Influenza B in real-world settings.
As with all rapid diagnostic tests, there is a risk of false positive and false negative results. Individuals who test positive for either flu or COVID-19 should take appropriate precautions to avoid spreading the virus and should seek follow-up care with their physician or healthcare provider as additional testing may be necessary. Negative results for SARS-CoV-2 and influenza B should be confirmed, if necessary for patient management, with an authorized or cleared molecular test performed in a CLIA-certified laboratory that meets requirements to perform high or moderate complexity tests. Individuals who test negative and continue to experience symptoms of fever, cough and/or shortness of breath may still have a respiratory infection and should seek follow up care with their healthcare provider.
The collective impact of COVID-19, flu and RSV underscore the importance of diagnostic tests for respiratory viruses, and the FDA recognizes the benefits that home testing can provide. The agency will continue to use its authorities to increase the number of appropriately accurate and easy to use at-home tests available to the public, especially tests that detect these highly contagious respiratory viruses.
Source: FDA
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FDA CDC News
Important Recall Alert – Listeria Contamination in Meal Kits
In recent news, Reser’s Fine Foods has issued a recall on several of its popular meal kits due to potential contamination with Listeria monocytogenes, a harmful bacteria known to cause food poisoning. This recall was prompted by the inclusion of chicken from their ingredient supplier, BrucePac, which has also been recalled due to contamination concerns.
What Products Are Affected?
The affected meal kits include a variety of delicious options that many consumers may have purchased. These products consist of:
- Taco Meal Kits
- Enchilada Meal Kits
- Quesadilla Meal Kits
- Stir Fry Meal Kits
- Salad Meal Kits
All of these products have been classified under a Class II recall by the U.S. Food and Drug Administration (FDA), indicating that while exposure may lead to temporary or medically reversible health consequences, the probability of serious adverse health effects is remote.
Understanding Listeria
Listeria monocytogenes is a bacterium that can lead to listeriosis, a serious infection typically caused by eating contaminated food. Symptoms can include fever, muscle aches, and gastrointestinal issues. Pregnant women, newborns, older adults, and individuals with weakened immune systems are particularly vulnerable to severe outcomes from listeriosis.
What Should Consumers Do?
If you have purchased any of the affected meal kits, it is crucial to check the packaging for any recall notices. Consumers should discard any recalled products or return them to the place of purchase for a refund. It is also advisable to stay informed by checking official announcements from the FDA and Reser’s Fine Foods regarding the recall.
Stay Informed
For the latest updates and more detailed information about this recall, visit the following resources:
Stay vigilant and prioritize your health by being aware of food recalls and potential safety issues. Your safety is paramount, so always make sure to stay informed about the food products you consume.
Related link:
https://www.newsweek.com/taco-meal-kit-recall-30-states-fda-1978552
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Daily News
Is There an E. Coli Outbreak at McDonald’s? What You Need to Know
McDonald’s faces an E. coli outbreak linked to Quarter Pounders, with 75 cases reported. The company is investigating potential onion contamination and prioritizing customer safety.
In the fast-paced world of fast food, health and safety are paramount. Recently, McDonald’s has been at the center of an alarming E. coli outbreak linked to their popular Quarter Pounders. With at least 75 reported cases across 13 states, including serious hospitalization and even a death, many consumers are understandably concerned. Let’s break down the situation, what officials are saying, and how McDonald’s is responding to the crisis.
The Details of the Outbreak
Reports have confirmed that this E. coli outbreak is associated with Quarter Pounders sold across various McDonald’s locations. As of now, Colorado and Montana have recorded the highest number of illnesses, causing health officials to raise the alarm. The symptoms of E. coli infection can be severe and include stomach cramps, diarrhea, and vomiting, which can lead to life-threatening complications, especially in vulnerable populations.
Possible Cause: Onions?
Amidst this distressing news, McDonald’s has identified a potential link to onions used in their Quarter Pounder recipe. While investigations are ongoing, the company is taking proactive measures by gradually reintroducing the Quarter Pounder to their menu without the traditional onions. This decision reflects their commitment to ensuring customer safety while addressing supply issues that may have arisen from the outbreak.
McDonald’s Response
In light of the ongoing investigation, McDonald’s has expressed its dedication to maintaining high food safety standards. They have collaborated closely with health officials, including the U.S. Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA), to trace the source of the contamination and prevent further incidents.
As they navigate this situation, the fast-food giant is emphasizing transparency with their customers. They have urged people to stay informed through official communication channels and monitor updates about the progress of the outbreak and safety measures being undertaken.
Consumer Safety: What Can You Do?
As the situation unfolds, it is essential for consumers to remain vigilant about their food choices:
- Stay Updated: Follow news reports and health advisories to keep track of the latest developments regarding this outbreak and any additional safety alerts.
- Practice Good Hygiene: Always wash your hands before eating, and keep an eye on cleanliness when dining out.
- Consider Menu Options: If you’re concerned about the outbreak, consider ordering items that do not contain ingredients linked to health risks or opt for menu items that have been specifically noted as safe.
- Know the Symptoms: Familiarize yourself with the signs of E. coli infection, and if you or someone you know experiences severe symptoms following a visit to McDonald’s, seek medical attention immediately.
The recent E. coli outbreak tied to McDonald’s Quarter Pounders has undoubtedly raised concerns among consumers, but the company is actively working to address the situation and safeguard the health of its patrons. While it’s human nature to worry about food safety, especially with such a concerning issue at hand, it’s also important to empower ourselves with knowledge and the right precautions.
As McDonald’s rolls out their menu changes, we hope that they can swiftly resolve this situation, ensuring that everyone can enjoy their meals with renewed confidence. Let’s all take a moment to prioritize food safety in our daily dining habits, and keep the conversation going around this crucial topic. Always stay informed, stay safe, and enjoy your meals wisely!
Read the release from McDonald’s corporate news site https://corporate.mcdonalds.com/corpmcd/our-stories/article/always-putting-food-safety-first.html
At our core, we at STM Daily News, strive to keep you informed and inspired with the freshest content on all things food and beverage. From mouthwatering recipes to intriguing articles, we’re here to satisfy your appetite for culinary knowledge.
Visit our Food & Drink section to get the latest on Foodie News and recipes, offering a delightful blend of culinary inspiration and gastronomic trends to elevate your dining experience.
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Lifestyle
Mac and Cheese Recall: Potential Spoilage Concerns Affect Products at Major Retailers
Mac and Cheese Recall
In a recent announcement by the Food and Drug Administration (FDA), two types of macaroni and cheese products sold at major retailers have been recalled due to concerns over potential spoilage. The recall affects Reser’s American Classics Macaroni & Cheese and Reser’s American Classics Macaroni & Cheese White Cheddar, as part of a broader recall of Reser’s Fine Foods deli salads and refrigerated items.
Scope of the Recall
The affected macaroni and cheese varieties were distributed across five states: California, Illinois, Minnesota, North Dakota, and South Dakota. The specific “use by” dates for the recalled products are as follows:
- Reser’s American Classics Macaroni & Cheese: Use by dates of September 14 and September 16, 2024.
- Reser’s American Classics Macaroni & Cheese White Cheddar: Use by date of September 11, 2024.
In addition to the macaroni and cheese products, the recall includes a variety of other items such as potato salad, scalloped potatoes, pasta salad, corn, egg salad, spinach dip, gravy, and various desserts.
Cause of the Recall
According to the FDA, the potential spoilage was linked to “temperature abuse” during transportation, specifically due to a malfunctioning refrigeration unit on a trailer. A representative from Reser’s Fine Foods confirmed to FOX Business that the issue was isolated to a single truckload of product delivered to only one distributor location.
“The recall was initiated on July 29, 2024, and no affected products ever made it to the store shelves,” the representative stated. They further reassured consumers that any items purchased from stores are safe to consume.
Retailer Responses
Major retailers, including Safeway, Stop & Shop, and Walmart, which stock Reser’s macaroni and cheese products, have stated that their stores were not impacted by the recall. However, Target, another retailer selling the products, did not provide a comment when contacted by FOX Business.
Consumer Safety First
The FDA and Reser’s Fine Foods have stressed the importance of consumer safety in this situation. While the affected products have not reached store shelves, customers who may have purchased any items from the recalled batch are encouraged to check the packaging for the specified “use by” dates.
As always, consumers are advised to be vigilant about food safety and to report any concerns to their local health department or the FDA. For those who may have questions or require further information regarding this recall, contacting Reser’s Fine Foods directly or checking the FDA’s website can provide additional clarity.
In conclusion, while the recent recall raises concerns over food safety, companies and regulatory agencies are working diligently to ensure that consumers remain informed and protected. As the situation develops, staying updated through reliable sources is essential for maintaining food safety standards in your household.
Read the story on Fox Business.com: https://www.foxbusiness.com/lifestyle/mac-cheese-sold-major-retailers-recalled-potential-spoiling
At our core, we at STM Daily News, strive to keep you informed and inspired with the freshest content on all things food and beverage. From mouthwatering recipes to intriguing articles, we’re here to satisfy your appetite for culinary knowledge.
Visit our Food & Drink section to get the latest on Foodie News and recipes, offering a delightful blend of culinary inspiration and gastronomic trends to elevate your dining experience.
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Subscribe to get the latest posts sent to your email.
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