US Recall News

United States Recall News Alerts for Recalled Drugs, Food, Products, & Vehicles

MENUMENU
  • Home
  • About
    • Advertise
  • Full Recall News Archive
    • Top Story

      J&J Settles Talc Mesothelioma Settlement

      By Sandra Dalton, Staff Writer On January 6, 2020, Superior Court Judge Stephen Kaus announced that Johnson & Johnsons (J&J) had agreed to … [Read More...]

      LLK Trading Inc. Recalls “Needle Mushrooms” Because of Possible Health Risk

      Summary Company Announcement Date: July 11, 2025 FDA Publish Date: July … [Read More...]

    • More Safety Articles
    • Federal Preemption of State Product Liability Law
  • Drug Recalls
    • Abilify
    • Benicar
    • Fluoroquinolones
    • Invokana
    • Lipitor
    • Nuplazid
    • Opioids
    • OxyContin
    • Pradaxa
    • Proton Pump Inhibitors (PPIs)
    • Risperdal
    • SSRI
    • Symptoms & Side Effects
    • Taxotere
    • Testosterone
    • Uloric
    • Valsartan
    • Xarelto
    • Zofran
  • Medical Devices
    • 3M Earplug
    • 3T Heater-Cooler System
    • Bair Hugger
    • Bipolar Hip System
    • Essure
    • Hip Replacements
    • Implanon
    • IVC Filters
    • Hernia Mesh
    • Power Morcellators
    • Shoulder Implants
    • Transvaginal Mesh
  • Food Recalls
    • FDA Press Releases
    • USDA Press Releases
  • Auto Recalls
    • Air Bags
    • Ignitions
    • NHTSA Press Releases
    • Off-Road Utility Vehicles
    • Snowmobiles
    • Tires
  • Other Products
    • Asbestos
    • Baby Products
    • Pet Products
    • Roundup
    • Talcum Powder
    • Toy Recalls
You are here: Home / Safety News / Magellan Blood Tests Show Inaccurate Lead Levels According to FDA

Magellan Blood Tests Show Inaccurate Lead Levels According to FDA

June 14, 2017 By Zac Pingle Leave a Comment

According to an investigation led by the Food and Drug Administration (FDA), the Magellan venous blood testing system has reportedly misrepresented lead levels in blood tests across the United States. The Centers for Disease Control and Prevention (CDC), recommends that pregnant mothers who have used the Magellan system be retested, as well as children under the age of six who’ve had blood test results of ten micrograms of lead or less per deciliter of blood.

An Understated Truth

The manufacturer of the Magellan venous blood test system, Magellan Diagnostics, is currently under investigation and the FDA and CDC report that the problem may have started as far back as 2014. Director of the FDA’s Center for Devices and Radiological Health, Jeffrey Shuren, stated in a conference call that the “root cause” of the Magellan testing defect has not been determined yet, though the investigation is still in its early phases. Magellan, a Massachusetts based company, currently has products in use around the country that make up for 300,000 venous blood tests each year.

The FDA claims that Magellan received complaints regarding the accuracy of its venous blood testing system in 2014, and that Magellan deemed that “the risks were negligible” and the inaccuracy could be solved by delaying processing for 24 hours, according to the investigation. In 2015, Magellan submitted a malfunction report to the FDA, while claiming that the incident was “not likely to cause adverse health consequences.”

According to Shuren, the FDA did not become concerned about Magellan blood tests until April, 2017, when the company requested a label change. To do so, Magellan would need to pass a common standard in FDA clearance by demonstrating that their product was as safe and effective — and in this case accurate — as another similar product that is currently on the market.

The Effect of Inaccurate Blood Tests

Though the Magellan venous blood test is under investigation, there are still other, more common, forms of blood tests available. Typically, and especially in the case of children, blood testing for lead is conducted with a finger or heel prick known as a “capillary test.” It’s only when a capillary test shows elevated levels of lead that a doctor would use a venous test to confirm the results.

Centers for Medicare and Medicaid official, Tim Hill, stated that Medicaid would cover the costs for retesting children on the program, and that those who are covered by private insurance should ask their health plan providers about retesting.

Director of CDC’s National Center for Environmental Health, Patrick Breysse, stated that the agency is keeping an eye on populations in areas like Flint, Michigan, where the chances of lead poisoning are more likely than other parts of the country. Though Breysse also estimated that “less than one percent” of children in Flint would be at risk for inaccurate blood test results.

Share this:

  • Click to share on Facebook (Opens in new window) Facebook
  • Click to share on X (Opens in new window) X
  • Click to share on LinkedIn (Opens in new window) LinkedIn
  • Click to email a link to a friend (Opens in new window) Email
  • Click to print (Opens in new window) Print

Related

Filed Under: Medical Devices, Safety News

Leave a ReplyCancel reply

This site uses Akismet to reduce spam. Learn how your comment data is processed.

Facebook
Thomas Roney LLC
Economic Consulting
Accident Attorneys

J&J Settles Talc Mesothelioma Settlement

January 15, 2020 By Advice Media

LLK Trading Inc. Recalls “Needle Mushrooms” Because of Possible Health Risk

July 10, 2025 By The FDA

Hartford Bakery, Inc. Issues Allergy Alert on Undeclared Hazelnuts in “Lewis Bake Shop Artisan Style ½ Loaf”

July 10, 2025 By The FDA

Wiet Peeters Farm Products Limited RECALLS “Aunt Mid’s Fresh Sliced Mushrooms, Peeters Mushroom Farm Cremini Sliced and Peeters Mushroom Farm Thick Slice Mushroom ” Because of Possible Listeria Monocytogenes Contamination

July 10, 2025 By The FDA

Hero Highlight

J&J Settles Talc Mesothelioma Settlement

January 15, 2020 By Advice Media

Giant Bicycle Recalls Momentum Vida E+ E-Bikes Due to Crash Hazard

July 9, 2025 By The CPSC

SPPTTY Kids Bicycles Recalled Due to Risk of Death or Injury from Lead Poisoning; Violates Federal Lead Content Ban; Sold at Walmart by Shenzhen Yihuachuang Technology

July 9, 2025 By The CPSC

AUGNORYE Padded Crib Bumpers Recalled Due to Risk of Serious Injury or Death from Suffocation; Violates Federal Crib Bumper Ban; Sold on Amazon by YIXIA

July 9, 2025 By The CPSC

Braided Crib Bumpers Recalled Due to Risk of Serious Injury or Death from Suffocation; Violates Federal Crib Bumper Ban; Sold on Amazon by Haoyunm

July 9, 2025 By The CPSC

Creekliybear Play Yard Mattresses Recalled Due to Risk of Serious Injury or Death from Entrapment Hazard; Violates Mandatory Standard for Crib Mattresses; Sold on Amazon by Kbabyea

July 9, 2025 By The CPSC

J&J Settles Talc Mesothelioma Settlement

January 15, 2020 By Advice Media

Braided Crib Bumpers Recalled Due to Risk of Serious Injury or Death from Suffocation; Violates Federal Crib Bumper Ban; Sold on Amazon by Haoyunm

July 9, 2025 By The CPSC

Creekliybear Play Yard Mattresses Recalled Due to Risk of Serious Injury or Death from Entrapment Hazard; Violates Mandatory Standard for Crib Mattresses; Sold on Amazon by Kbabyea

July 9, 2025 By The CPSC

Dearlomum Retractable Safety Gates Recalled Due to Risk of Serious Injury or Death to Children from Entrapment Hazard; Violates Federal Standard for Gates and Enclosures; Sold on Amazon by Signbaby

July 9, 2025 By The CPSC

Recall News in Your Inbox

Enter your email address to receive automated recall news updates.

Recent Comments

  • Roger McGowan on ABH NATURE’S PRODUCTS, INC, ABH PHARMA, INC., and STOCKNUTRA.COM, INC. Issues Nationwide Recall of All Lots of Dietary Supplement Products
  • Kathryn Moore on FDA Wants Cancer Warning on Breast Implants
  • BRAD on Huge ATV Recall by Polaris – Sportsman and Scrambler
  • Crystal Anderson on Allergan Voluntarily Recalls BIOCELL® Textured Breast Implants and Tissue Expanders
  • Outsourcing Training on The Modern Marketing of Pain
  • SANDRA Collett on Processed Food Preservative Linked to Autism?
  • Eric Karsh on Health Risks of Roundup Go Well Beyond Cancer

Recent Posts

  • LLK Trading Inc. Recalls “Needle Mushrooms” Because of Possible Health Risk
  • Hartford Bakery, Inc. Issues Allergy Alert on Undeclared Hazelnuts in “Lewis Bake Shop Artisan Style ½ Loaf”
  • Wiet Peeters Farm Products Limited RECALLS “Aunt Mid’s Fresh Sliced Mushrooms, Peeters Mushroom Farm Cremini Sliced and Peeters Mushroom Farm Thick Slice Mushroom ” Because of Possible Listeria Monocytogenes Contamination
  • Walmart Recalls Ozark Trail 64 oz Water Bottles Due to Serious Impact and Laceration Hazards
  • WLIVE Fabric Dressers Recalled Due to Risk of Serious Injury or Death from Tip-Over and Entrapment Hazards; Violations of Federal Standard for Clothing Storage Units; Sold on Amazon by WLIVE
  • Giant Bicycle Recalls Momentum Vida E+ E-Bikes Due to Crash Hazard
  • SPPTTY Kids Bicycles Recalled Due to Risk of Death or Injury from Lead Poisoning; Violates Federal Lead Content Ban; Sold at Walmart by Shenzhen Yihuachuang Technology
  • AUGNORYE Padded Crib Bumpers Recalled Due to Risk of Serious Injury or Death from Suffocation; Violates Federal Crib Bumper Ban; Sold on Amazon by YIXIA
  • Braided Crib Bumpers Recalled Due to Risk of Serious Injury or Death from Suffocation; Violates Federal Crib Bumper Ban; Sold on Amazon by Haoyunm
-- See More Recall News

Disclaimer: The information contained in these topics is not intended nor implied to be a substitute for professional medical or legal advice, it is provided for educational purposes only. Always seek the advice of your physician or other qualified healthcare provider about any questions you may have regarding a medical condition. Nothing contained in these topics is intended to be used for medical diagnosis or treatment.


ATTORNEY ADVERTISING. The information provided on this website is not legal advice. No attorney-client relationship is formed by the use of this site. It is not stated or implied that a lawyer is certified as a specialist in any particular field of law. No results are guaranteed, and prior results do not guarantee a similar outcome. This site is informational, only, not dispositive; it is up to you to decide whether a particular lawyer is right for you. Use of this site is subject to your agreement to these.


Copyright © 2025 Altrumedia · Terms of Service · Log in