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 The Food and Drug Administration warned laboratories and healthcare
professionals not to use any lead testing device made by Magellan
Diagnostics, a company acquired by Meridian in 2016 for $66 million,
to test blood drawn from veins. The devices are the only lead
testing products cleared by the FDA and account for about half of
all lead tests in the United States.
The tests are designed to detect lead poisoning that can stunt
children's growth and reduce their IQs, according to the Centers for
Disease Control and Prevention.
Awareness of lead poisoning escalated following widespread exposure
in Flint, Michigan. Reuters has identified more than 3,300 areas
with childhood lead poisoning rates at least double those found in
the Michigan city.
The CDC recommended healthcare professionals retest children under
the age of 6 who were tested using blood drawn from a vein who
received a result of less than 10 micrograms per deciliter. It also
recommended that pregnant women and nursing mothers who have been
tested for lead exposure ask their doctor whether they should be
retested.
"The FDA is deeply concerned by this situation," Dr. Jeffrey Shuren,
head of the FDA's medical device division, said in a statement. "The
agency is aggressively investigating this complicated issue to
determine the cause of the inaccurate results and working with the
CDC and other public health partners to address the problem as
quickly as possible."
It is unclear how many people may need to be retested, Shuren said
on a conference call with reporters. About 8 million tests were
conducted using Magellan devices since 2014. Most people were tested
using capillary blood drawn with a heel stick or finger stick and so
far data suggests there is no problem with those tests.
"At this time we believe most people will not be affected by this
issue," Shuren said on a conference call with reporters.
Neither are there problems with other blood tests used to detect
lead, which account for about half the total, he said.
Magellan CEO Amy Winslow said the company does not expect a big
demand for retesting because the warning does not cover capillary
results. She said the company's Ultra and Plus systems, launched in
2013 and 2015 respectively, are typically used to analyze venous
blood, though they can analyze capillary blood as well.
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The problem with the venous blood testing appears to date back to
August 2014 when Magellan received a number of complaints from
customers about its LeadCare Ultra device, the FDA said. On Nov. 24,
the company instructed its customers to implement a 24-hour
incubation period with the blood sample before running the test. It
subsequently issued instructions to mitigate problems with its
LeadCare II testing system.
The FDA learned about the problem earlier this year when it began to
review an application for a new test. It discovered deficiencies in
the company's previous mitigation strategy and categorized the
problem as minor.
The agency "did not feel that the data was either adequate regarding
what they thought may have been the cause of the problem, the extent
of the problem or the effectiveness of the mitigation they put in
place," the FDA's Shuren said.
The company declined to comment on the FDA's statement that it had
minimized problems with its tests, citing the ongoing inquiry.
So far the cause of the problem is unclear.
"It may not be something specific to the test itself. It may have to
do with other aspects, including the tubes in which the blood is
collected. It may have to do with reactions with the chemicals
involved," he said.
(Reporting by Toni Clarke. Additional reporting by Natalie Grover in
Bengaluru, Michael Pell and Joshua Schneyer in New York; Editing by
Andrew Hay and Lisa Shumaker)
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