FRANKLIN LAKES, N.J.,
March 22, 2018 /PRNewswire/ -- 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.
About BD
BD is one of the largest global medical
technology companies in the world and is advancing the world of
health by improving medical discovery, diagnostics and the delivery
of care. The company supports the heroes on the frontlines of
health care by developing innovative technology, services and
solutions that help advance both clinical therapy for patients and
clinical process for health care providers. BD and its 65,000
employees have a passion and commitment to help improve patient
outcomes, improve the safety and efficiency of clinicians' care
delivery process, enable laboratory scientists to better diagnose
disease and advance researchers' capabilities to develop the next
generation of diagnostics and therapeutics. BD has a presence in
virtually every country and partners with organizations around the
world to address some of the most challenging global health issues.
By working in close collaboration with customers, BD can help
enhance outcomes, lower costs, increase efficiencies, improve
safety and expand access to health care. In 2017, BD welcomed C. R.
Bard and its products into the BD family. For more information on
BD, please visit bd.com.
Contacts:
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Troy
Kirkpatrick
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Monique N.
Dolecki
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BD Public
Relations
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BD Investor
Relations
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858.617.2361
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201.847.5378
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troy.kirkpatrick@bd.com
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Monique_Dolecki@bd.com
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SOURCE BD (Becton, Dickinson and Company)