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...]

      Shop Me Ca Recalls “Diep Bao Cream” Because of Possible Health Risk

      Summary Company Announcement Date: February 01, 2023 FDA Publish Date: … [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 / Food Recalls / FDA Press Releases / BD Updates Instructions for Use for Certain BD Vacutainer® Blood Collection Tubes

BD Updates Instructions for Use for Certain BD Vacutainer® Blood Collection Tubes

March 22, 2018 By The FDA Leave a Comment

BD (Becton, Dickinson and Company) (NYSE: BDX), a leading global medical technology company, today announced it is updating the instructions for use of certain BD Vacutainer® tubes as part of its quality process to ensure that customers understand the appropriate uses of these products.

Since BD became aware of the concerns about inaccurate lead test results from Magellan Diagnostics LeadCare® Testing Systems, the company has been cooperating fully with the U.S. Food and Drug Administration (FDA). BD launched an internal investigation and determined that Anodic Stripping Voltammetry (ASV) technology, which is used in Magellan LeadCare testing systems, is not compatible with thiuram, a material found in the rubber stoppers of the BD Vacutainer® EDTA Lavender, Pink and Tan top tubes and BD Vacutainer® Lithium Heparin Green top tubes. Thiuram has been in these rubber stoppers since 1996, however, the effect of thiuram on lead testing when used with ASV technology was only recently observed through the course of this investigation. As a result, BD is updating the instructions for use of its BD Vacutainer® Lavender, Pink and Tan top tubes and BD Vacutainer®  Lithium Heparin Green top tubes to include a precaution that these products are not recommended for lead testing when using Magellan Diagnostics LeadCare® assays employing the ASV methodology, or any other assay employing ASV methodology. Other lead testing systems, such as graphite furnace atomic absorption spectroscopy (GFAAS) and inductively coupled plasma mass spectrometry (ICP-MS) are not affected by this update. In addition, BD is not aware of any other instrumentation that uses ASV technology. BD Vacutainer® tubes have been on the market for more than 60 years and continue to have a track record of safe and effective use.

Instructions to Customers

Please refer to the customer letter for specific information at bd.com/ en-us/support/alerts-and-  notices/bd-edta-tubes-and-litium-heparin-tubes-ifu-update.

There is no need for customers to return any products to BD, and these products can continue to be used in accordance with the updated instructions for use.

Customers should continue to follow FDA’s safety communication for testing lead levels, which currently recommends that no venous blood should be tested with Magellan’s LeadCare test systems (regardless of the collection tube used).

Customers with inquiries related to this action may contact BD at 1-888-237-2762 (select Option #3 and then Option #4), Monday through Friday between 8 a.m. and 5 p.m. CDT.

Customers should report any adverse health consequences experienced with the use of these products to BD at the number above. Events may also be reported to the FDA’s MedWatch Adverse Event Reporting program:

  • Web: Medwatch website at www.fda.gov/medwatch
  • Phone: 1-800-FDA-1088 (1-800-332-1088)
  • Mail: MedWatch, HF-2, FDA 5600 Fisher’s Lane, Rockville, MD 20853-9787

BD believes that every member of the industry — from instrument manufacturers, to tube manufacturers to laboratory staff — plays a role in the validation of testing methods and tools used in the diagnostic process. BD remains committed to providing high-quality products and expertise to support accurate diagnostic testing, good specimen integrity and quality, and a safe environment for patients and health care workers.

###

Share this:

  • Facebook
  • Twitter
  • LinkedIn
  • Email
  • Print

Related

Filed Under: FDA Press Releases

About The FDA

The Food and Drug Administration (FDA) is an agency within the U.S. Department of Health and Human Services. It consists of the Office of the Commissioner and four directorates overseeing the core functions of the agency: Medical Products and Tobacco, Foods and Veterinary Medicine, Global Regulatory Operations and Policy, and Operations.

Leave a Reply Cancel reply

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

Facebook
Thomas Roney LLC
Economic Consulting

J&J Settles Talc Mesothelioma Settlement

January 15, 2020 By Advice Media

Shop Me Ca Recalls “Diep Bao Cream” Because of Possible Health Risk

February 1, 2023 By The FDA

B&G Foods Issues Voluntary Allergy Alert for Undeclared Peanut in Three Cases of Back to Nature® Fudge Mint Cookies

January 31, 2023 By The FDA

IBSA Pharma Inc. Issues Voluntary Nationwide Recall of Select Lots of TIROSINT®-SOL (levothyroxine sodium) Oral Solution Due to Subpotency

January 30, 2023 By The FDA

Hero Highlight

J&J Settles Talc Mesothelioma Settlement

January 15, 2020 By Advice Media

Sovos Brands Intermediate, Inc. Issues Allergy Alert on Undeclared Egg in Rao’s Slow Simmered Soup, Labeled as Chicken & Gnocchi but Containing Vegetable Minestrone

January 27, 2023 By The FDA

Edgewell Personal Care Issues Voluntary Nationwide Recall of Banana Boat Hair & Scalp Sunscreen Due to the Presence of Benzene – UPDATED

January 26, 2023 By The FDA

Joy Joy’s Bakery Issues Allergy Alert on Undeclared Wheat in Ube Spanish Bread, Ube Ensaymada, and Ube Roll

January 26, 2023 By The FDA

ZLINE Expands Recall of Gas Ranges to Include 48-inch Gas Ranges Due to Serious Risk of Injury or Death from Carbon Monoxide Poisoning

January 25, 2023 By The CPSC

Properly Tied Recalls Children’s Lounge Pants Due to Violation of Federal Flammability Standards and Burn Hazard

January 25, 2023 By The CPSC

J&J Settles Talc Mesothelioma Settlement

January 15, 2020 By Advice Media

ZLINE Expands Recall of Gas Ranges to Include 48-inch Gas Ranges Due to Serious Risk of Injury or Death from Carbon Monoxide Poisoning

January 25, 2023 By The CPSC

Properly Tied Recalls Children’s Lounge Pants Due to Violation of Federal Flammability Standards and Burn Hazard

January 25, 2023 By The CPSC

Snack Innovations Inc. Conducts Voluntary Recall on a Limited Quantity of Drizzilicious Mini Rice Cakes 4oz & .74oz and Popcorn 3.6oz Products in the U.S. Due to Undeclared Peanut Allergen on Packaging

January 25, 2023 By The FDA

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

  • Shop Me Ca Recalls “Diep Bao Cream” Because of Possible Health Risk
  • B&G Foods Issues Voluntary Allergy Alert for Undeclared Peanut in Three Cases of Back to Nature® Fudge Mint Cookies
  • IBSA Pharma Inc. Issues Voluntary Nationwide Recall of Select Lots of TIROSINT®-SOL (levothyroxine sodium) Oral Solution Due to Subpotency
  • Daiso Issues Allergy Alert on Undeclared Soy in Matsunga Mini Shiruko Sand Biscuits
  • Two Rivers Coffee Issues Allergy Alert on Undeclared Peanut Allergen in Peanut Butter Hot Chocolate
  • Sovos Brands Intermediate, Inc. Issues Allergy Alert on Undeclared Egg in Rao’s Slow Simmered Soup, Labeled as Chicken & Gnocchi but Containing Vegetable Minestrone
  • Edgewell Personal Care Issues Voluntary Nationwide Recall of Banana Boat Hair & Scalp Sunscreen Due to the Presence of Benzene – UPDATED
  • Joy Joy’s Bakery Issues Allergy Alert on Undeclared Wheat in Ube Spanish Bread, Ube Ensaymada, and Ube Roll
  • ZLINE Expands Recall of Gas Ranges to Include 48-inch Gas Ranges Due to Serious Risk of Injury or Death from Carbon Monoxide Poisoning
-- 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 © 2023 Altrumedia · Terms of Service · Log in