Chaotic lake getting fence and securityWhat we learned about Cape Coral’s water crisis after a ride along
LEHIGH ACRES Chaotic lake getting fence and security Now, with all the negative attention it has gotten, some think putting up a fence is a great way to keep that bad activity out.
CAPE CORAL What we learned about Cape Coral’s water crisis after a ride along On Friday, WINK News got to ride along to see just what people are doing that could be wasting water.
FORT MYERS Students affected by COVID-19 able to graduate for the first time For many young people, COVID stripped away one of their greatest rites of passage: graduation.
Deadly crash on State Road 29 in Hendry County Authorities are at the scene of a deadly crash on State Road 29 in Hendry County on Friday afternoon.
Celebrating Free Comic Book Day in SWFL JP Sports store manager Jonathan Powell said this is a generational event that brings families together to reminisce on comics and other hobby-related knickknacks.
FORT MYERS Group rescues dogs before getting put down in Lee County Our animal shelters are packed with amazing puppies who have the sole desire to be loved.
FORT MYERS FGCU student beats all odds and is able to graduate Nearly four years ago, Marisa Manning had her heart set on going to Florida Gulf Coast University but never thought she’d find her passion for studying parasites.
FORT MYERS Victim in MLK Blvd. shooting identified as social media influencer The victim of the Martin Luther King Boulevard shooting has been identified as a local social media influencer.
FORT MYERS Could a Ferris wheel in downtown Fort Myers work? Right now, there are talks to bring a Ferris wheel to downtown Fort Myers, but several things are still up in the air.
LITTLE HICKORY BAY Improving ‘Hell’s Gate’ safety, a notoriously dangerous waterway for boaters A push to make an area known as “Hell’s Gate” safer since it’s a dangerous stretch of water with several blind corners within Little Hickory Bay.
Fixing failed back surgeries More than a million and a half people in the U.S. undergo back surgery each year. However, classic back surgery has one of the highest failure rates of any surgery.
WINK NEWS Getting an inside look at the FEMA discount controversy Picking up the pieces after Hurricane Ian has been difficult for many and moving on can impact our wallets.
FGCU FGCU pitcher Dylan Wolff playing for hometown team after labrum injury FGCU pitcher Dylan Wolff is living the dream playing for the hometown team after he overcame a labrum injury.
LEHIGH ACRES Frustrated Lehigh parents want action after violent school fights go viral online Violence at a Lehigh Acres Middle school was captured and posted online.
Turtle Club beachfront restaurant relaunches in Naples After a series of private friends and family events this week, The Turtle Club will reopen May 5 and begin taking reservations again May 6.
LEHIGH ACRES Chaotic lake getting fence and security Now, with all the negative attention it has gotten, some think putting up a fence is a great way to keep that bad activity out.
CAPE CORAL What we learned about Cape Coral’s water crisis after a ride along On Friday, WINK News got to ride along to see just what people are doing that could be wasting water.
FORT MYERS Students affected by COVID-19 able to graduate for the first time For many young people, COVID stripped away one of their greatest rites of passage: graduation.
Deadly crash on State Road 29 in Hendry County Authorities are at the scene of a deadly crash on State Road 29 in Hendry County on Friday afternoon.
Celebrating Free Comic Book Day in SWFL JP Sports store manager Jonathan Powell said this is a generational event that brings families together to reminisce on comics and other hobby-related knickknacks.
FORT MYERS Group rescues dogs before getting put down in Lee County Our animal shelters are packed with amazing puppies who have the sole desire to be loved.
FORT MYERS FGCU student beats all odds and is able to graduate Nearly four years ago, Marisa Manning had her heart set on going to Florida Gulf Coast University but never thought she’d find her passion for studying parasites.
FORT MYERS Victim in MLK Blvd. shooting identified as social media influencer The victim of the Martin Luther King Boulevard shooting has been identified as a local social media influencer.
FORT MYERS Could a Ferris wheel in downtown Fort Myers work? Right now, there are talks to bring a Ferris wheel to downtown Fort Myers, but several things are still up in the air.
LITTLE HICKORY BAY Improving ‘Hell’s Gate’ safety, a notoriously dangerous waterway for boaters A push to make an area known as “Hell’s Gate” safer since it’s a dangerous stretch of water with several blind corners within Little Hickory Bay.
Fixing failed back surgeries More than a million and a half people in the U.S. undergo back surgery each year. However, classic back surgery has one of the highest failure rates of any surgery.
WINK NEWS Getting an inside look at the FEMA discount controversy Picking up the pieces after Hurricane Ian has been difficult for many and moving on can impact our wallets.
FGCU FGCU pitcher Dylan Wolff playing for hometown team after labrum injury FGCU pitcher Dylan Wolff is living the dream playing for the hometown team after he overcame a labrum injury.
LEHIGH ACRES Frustrated Lehigh parents want action after violent school fights go viral online Violence at a Lehigh Acres Middle school was captured and posted online.
Turtle Club beachfront restaurant relaunches in Naples After a series of private friends and family events this week, The Turtle Club will reopen May 5 and begin taking reservations again May 6.
Credit: BD Max The U.S. Food and Drug Administration (FDA) alerted clinical laboratory staff and health care providers of an increased risk of a false-positive result with BD SARS-CoV-2 Reagents for the BD Max System test. In one study, the manufacturer found approximately three percent (3%) of results were false-positive results. WINK News reached out to local testing sites. We can confirm, the CenturyLink Sports Complex site does not use the BD Max System tests. We are still awaiting a reply from other testing sites. Recommendations The FDA recommends clinical laboratory staff and health care providers: Consider any positive result presumptive from tests using the BD SARS-CoV-2 Reagents for the BD Max System. Consider confirming with an alternate authorized test. Report any issues with using COVID-19 tests to the FDA. See Reporting Problems to the FDA below. Background The BD SARS-CoV-2 Reagents for BD Max System test is only authorized for use in laboratories in the United States certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) to perform moderate and high complexity tests. The test is designed to detect viral nucleic acid from the virus that causes COVID-19 in upper respiratory specimens, such as nasal swabs. This letter only applies to the BD SARS-CoV-2 Reagents for the BD Max System. The test received an Emergency Use Authorization on April 8, 2020. FDA Actions The FDA is working with Becton, Dickinson and Company (BD) to resolve this issue. The FDA will continue to keep clinical laboratory staff, health care providers, manufacturers, and the public informed of new or additional information. Additional Resources Fact Sheet for Health Care Providers: BD SARS-CoV-2 Reagents for BD Max System FAQs on Testing for SARS-CoV-2 In Vitro Diagnostics EUAs Reporting Problems to the FDA The FDA encourages health care providers to report any adverse events or suspected adverse events experienced with tests using the BD SARS-CoV-2 Reagents for the BD Max System. Voluntary reports can be submitted through MedWatch, the FDA Safety Information and Adverse Event Reporting program. Device manufacturers and user organizations must comply with the applicable Medical Device Reporting (MDR) regulations. Health care personnel employed by organizations that are subject to the FDA’s user facility reporting requirements should follow the reporting procedures established by their organizations. Prompt reporting of adverse events can help the FDA identify and better understand the risks associated with medical devices.