FDA CDC News

FDA Clears First Over-the-Counter Antigen Test for COVID-19

FDA clears 1st OTC antigen test for COVID-19 by ACON Labs. Safe, accurate, and indicated for children. Expanding access to at-home testing. #COVID19 #FDA

Published

9 months ago

November 10, 2023

Rod Washington

The U.S. Food and Drug Administration (FDA) has taken a significant step in expanding access to COVID-19 testing by clearing the marketing of the first over-the-counter (OTC) antigen test. ACON Laboratories’ Flowflex COVID-19 Antigen Home Test, previously authorized for emergency use, has now undergone a traditional FDA premarket review pathway and is the second home COVID-19 test to receive such clearance. Notably, it is also the first test indicated for use in children under 18. This development aligns with the FDA’s commitment to advancing at-home testing options for various medical conditions, thus enhancing patient access to testing.

Advancing Access to At-Home Testing:
Jeff Shuren, M.D., J.D., director of the FDA’s Center for Devices and Radiological Health, highlighted the significance of this achievement, stating, “This marks the latest step forward in our efforts to help test developers provide Americans with continued options for safe and effective COVID tests that can be performed entirely at home.” The FDA’s proactive collaboration with test developers seeking to market their products beyond emergency use authorization underscores their commitment to expanding patient access to testing and supporting the development of at-home tests for various medical conditions.

Flowflex COVID-19 Antigen Home Test:
The Flowflex COVID-19 Antigen Home Test is an OTC test designed for symptomatic individuals within six days of symptom onset. It is cleared for use by individuals aged 14 years or older testing themselves or adults testing individuals aged two years or older. In an FDA-reviewed study, this test demonstrated impressive accuracy, correctly identifying 89.8% of positive and 99.3% of negative samples in individuals displaying signs and symptoms of upper respiratory infection.

Testing Guidelines:
Similar to antigen tests authorized for emergency use, the Flowflex COVID-19 Antigen Home Test should be used at least twice over a three-day period, with a minimum of 48 hours between tests. This means that if a symptomatic individual initially receives a negative test result, they should be re-tested once between 48 and 72 hours after the first test using an antigen test for COVID-19 or follow up with a molecular COVID-19 test.

510(k) Premarket Review Pathway:
The FDA reviewed the ACON Flowflex COVID-19 Antigen Home Test through the 510(k) premarket review pathway. The 510(k) is a submission made to the FDA to demonstrate that a new device is substantially equivalent to a legally marketed predicate device. This detailed review process ensures the safety and effectiveness of the test and provides confidence to consumers who choose to utilize it.

The FDA’s clearance of the Flowflex COVID-19 Antigen Home Test as the first over-the-counter antigen test for COVID-19 represents a significant milestone in expanding access to testing. This advancement allows individuals, including children, to conveniently and accurately test for COVID-19 from the comfort of their homes. With the ongoing commitment of organizations like the FDA and test developers, we can continue to develop and enhance at-home testing options, ultimately helping to control the spread of COVID-19 and improve public health.

https://www.fda.gov/news-events/press-announcements/fda-clears-first-covid-19-home-antigen-test?utm_medium=email&utm_source=govdelivery

About the FDA:
The FDA, as an agency within the U.S. Department of Health and Human Services, plays a vital role in assuring the safety, effectiveness, and security of various healthcare products and regulating industries that impact public health. From drugs and vaccines to medical devices and food safety, the FDA is dedicated to protecting and promoting the well-being of the American public.

Source: FDA

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Author

Rod Washington

Rod: A creative force, blending words, images, and flavors. Blogger, writer, filmmaker, and photographer. Cooking enthusiast with a sci-fi vision. Passionate about his upcoming series and dedicated to TNC Network. Partnered with Rebecca Washington for a shared journey of love and art.
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Rod Washington

Rod: A creative force, blending words, images, and flavors. Blogger, writer, filmmaker, and photographer. Cooking enthusiast with a sci-fi vision. Passionate about his upcoming series and dedicated to TNC Network. Partnered with Rebecca Washington for a shared journey of love and art.

Lifestyle

Important Recall Alert: Expanded Produce Recall Due to Listeria Concerns

Published

3 days ago

July 23, 2024

Charles Elliot, Daily News Staff

In a significant public health alert, the Ohio Department of Agriculture (ODA) has announced an expanded recall of fresh produce supplied by Wiers Farm Inc., based in Huron County. This comes amidst growing concerns about potential listeria contamination, prompting vigilance among consumers shopping at select retailers, including Walmart, Aldi, and Kroger stores across Ohio and several other states.

people at supermarket. recall — Photo by Sebastián Mera Jaramillo on Pexels.com

What You Need to Know

On July 22, 2024, Wiers Farm Inc. expanded its voluntary recall to include additional produce items that were packed between July 5 and July 12. While there have been no reported illnesses or consumer complaints to date, the ODA is taking proactive measures to ensure public safety.

Affected Products

The recall includes a variety of retail packaged items and bulk produce sold at various grocery chains. Here’s a comprehensive list of the impacted products:

Retail Packaged Items

Sold at select Walmart stores in multiple states:

Wiers Farm Bagged Poblano – UPC 073064202581 – 16 oz bag
Wiers Farm Bagged Cubanelle – UPC 073064201836 – 16 oz bag
Wiers Farm Bagged Green Beans – UPC 073064200846 – variable weight bag
Wiers Farm Bagged Salad Cucumber – UPC 073064459619 – 2 lb. bag
Wiers Farm Bagged Serrano – UPC 073064201829 – 4 oz bag
Wiers Farm Organic Bell Pepper – UPC 073064201416 – 2 count tray
Wiers Farm Organic Cucumber – UPC 073064201423 – 2 count tray
Wiers Farm Organic Yellow Squash – UPC 073064201447 – 2 count tray
Wiers Farm Organic Zucchini Squash – UPC 073064201430 – 2 count tray

Sold at Aldi stores in Ohio and nearby states:

Freshire Farms Bagged Green Beans – 16 oz bag
Freshire Farms Bagged Jalapenos – 8 oz bag

Bulk Retail Items (sold individually or by the pound)

Anaheim peppers
Cilantro (sold in bunches)
Cubanelle peppers
Whole cucumbers
Green beans
Green Bell Pepper
Habanero peppers
Hungarian Wax peppers
Jalapeno peppers
Mustard Greens (sold in bunches)
Poblano peppers
Serrano peppers
Tomatillos

In Ohio, these bulk items were distributed to Walmart, Kroger, Save-a-Lot, and local food banks in Cleveland and Youngstown.

What Should Consumers Do?

The ODA is urging consumers who may have purchased any of the listed products to discard them immediately. It’s crucial to stay informed, as listeria monocytogenes can lead to serious health issues, particularly in vulnerable populations such as pregnant women, the elderly, and those with weakened immune systems. Symptoms of listeriosis can include fever, muscle aches, and gastrointestinal distress—anyone experiencing these symptoms after consuming the recalled products should seek medical attention promptly.

Commitment to Safety

Wiers Farm Inc. has expressed its dedication to resolving this situation and ensuring the safety of its products. The ODA is actively investigating the matter, a response initiated after potential contamination was flagged during routine testing by the Michigan Department of Agriculture and Rural Development.

Stay Informed

For further inquiries or concerns, consumers can reach out to Wiers Farm at 419-933-2161. It’s essential to stay updated on recalls and food safety alerts to protect your health and the health of your loved ones.

As we navigate through these recalls, let’s remain vigilant and prioritize food safety to ensure a healthy dining experience for everyone. Remember, when in doubt, it’s better to be safe than sorry—check your pantry and fridge today!

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Consumer Corner

Important Recall Notice: Wiers Farm, Inc. Announces Voluntary Recall of Cucumbers Due to Listeria Concerns

Wiers Farm recalls cucumbers due to Listeria risk. Discard affected products immediately.

Published

1 week ago

July 19, 2024

Hal Machina, Daily News Staff

In a decisive move to ensure consumer safety, Wiers Farm, Inc., a respected distributor based in Willard, OH, has announced a voluntary recall of select cucumber products over concerns of potential contamination with Listeria monocytogenes. This recall specifically targets a limited number of whole and bagged salad cucumbers, sourced from out of state and distributed under the Wiers Farm brand.

Recall Details

Date of Announcement: July 12, 2024
FDA Publish Date: July 16, 2024
Product Types: Whole cucumbers and 2 lb bagged salad cucumbers
Pack Dates: June 5, 2024 (whole cucumbers), June 5 and 6, 2024 (salad cucumbers)
Distribution: Select Walmart stores in Michigan, Indiana, and Ohio

Reason for Recall

The potential for contamination was identified through routine sampling by the Michigan Department of Agriculture and Rural Development (MDARD). While no illnesses or customer complaints have been reported to date, Wiers Farm is proceeding with the utmost caution to safeguard its customers.

About Listeria

Listeria monocytogenes is a bacteria capable of causing the serious infection known as listeriosis. It primarily affects pregnant women, newborns, the elderly, and adults with weakened immune systems. Symptoms include fever, muscle aches, nausea, and diarrhea. If you have consumed any of the recalled products and are experiencing these symptoms, it is advised to seek medical attention promptly. More information about Listeria can be found on the Centers for Disease Control and Prevention (CDC) website.

Product Identification

Whole Cucumbers: Approximately 1.5-2.5 inches in diameter and 6-9 inches in length
Bagged Salad Cucumers: Packaged in a clear bag with a blue base, marked with the specified pack dates

Consumer Action

Consumers in possession of the affected cucumbers are urged not to consume them. Even though the products are past their shelf life and likely out of distribution, if you still have them, please safely dispose of them immediately. Questions or concerns can be addressed by contacting Wiers Farm customer care at (419) 933-2161 or via email at customercare@wiersfarm.com.

Company Statement

Wiers Farm has expressed its commitment to the highest standards of food safety and health. “We have taken immediate steps to address this isolated incident and are collaborating closely with the Ohio Department other traceability data to ensure that the product in question is swiftly and effectively removed from all channels,” stated a company spokesperson.

Summary

This recall serves as a reminder of the importance of stringent safety measures in the food distribution process. Wiers Farm’s proactive steps in recalling potentially affected products underscore their dedication to consumer safety and health standards. Consumers are advised to follow recall instructions and dispose of any questionable products to ensure health and safety.

FDA notice: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/wiers-farm-inc-issues-voluntary-recall-whole-and-salad-cucumbers-due-possible-contamination-listeria

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FDA CDC News

Immediate Recall Alert: Reser’s Fine Foods Announces Voluntary Recall of Hill Country Fare Mustard Potato Salad

Reser’s recalls Hill Country Fare Mustard Potato Salad due to potential plastic contamination. Return for a refund if purchased.

Published

1 week ago

July 18, 2024

Charles Elliot, Daily News Staff

In a decisive action prioritizing consumer safety, Reser’s Fine Foods has issued a voluntary recall for one of its popular products, the Hill Country Fare Mustard Potato Salad, available in 48 oz (3LB) containers. This recall specifically targets products with a Use By Date of JUL/26/24. The reason behind this precautionary step is the discovery of potential contamination from pieces of hard plastic, which could present a health risk to consumers.

Key Details of the Mustard Potato Salad Recall:

Company Announcement Date: July 02, 2024
FDA Publish Date: July 09, 2024
Product Type: Food & Beverages
Reason for Recall: Possibility of Hard Plastic Foreign Material
Company Name: Reser’s Fine Foods
Brand Name: Hill Country Fare
Product Description: Mustard Potato Salad

This product was exclusively distributed through H-E-B and Joe V’s Smart Shop stores located within Texas and was produced at a regional facility operated by Reser’s Fine Foods. It is important to note that, fortunately, no injuries or adverse effects have been reported as of now.

Consumer Safety Measures

To prevent any potential hazards, all affected product batches have been removed from retail shelves. Reser’s urges consumers who have purchased this specific product to avoid consuming it. Instead, they should return it to the store where it was purchased for a full refund or safely dispose of it.

Contact Information for Consumer Inquiries:

For those with further questions or in need of additional information regarding this recall, Reser’s Fine Foods has made provisions for customer communication. You can reach them at:

Phone: 888-223-2127
Operational Hours: Monday to Friday, from 8:00 AM to 5:00 PM Pacific Time.

Why This Recall Matters

Recalls are a vital part of ensuring safety in the food supply chain. Reser’s Fine Foods has taken this proactive step out of an abundance of caution to protect its consumers from any possible harm. Such actions reflect a commitment to high standards of food safety and consumer protection.

Taking Action

If you have purchased the recalled Hill Country Fare Mustard Potato Salad, check the packaging for the specified Use By Date, and follow the outlined safety guidelines. It’s also wise to keep abreast of updates from Reser’s Fine Foods and the FDA.

This voluntary recall showcases the importance of rigorous quality checks and responsiveness in addressing any potential risk swiftly. For continued safety, keep informed about the latest food recalls and guidelines issued by health and food safety organizations.

Closing Thoughts

Reser’s Fine Foods remains dedicated to upholding the highest levels of safety and quality and is actively working on measures to prevent future issues. Consumers can rest assured that swift actions like these reflect a commitment to their well-being.

For continuous updates, stay tuned to the FDA’s announcements or sign up for direct alerts from food safety authorities to ensure you and your lovedators are always protected.

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/resers-fine-foods-announces-voluntary-recall-hill-country-fare-mustard-potato-salad-use-date-jul2624

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