(Corrects paragraph 12 to show FDA reviewed application for
label change to a test, not a new test)
By Toni Clarke
WASHINGTON May 17 U.S. health officials on
Wednesday warned that tests made by Meridian Bioscience Inc
may underestimate lead levels in blood drawn from
veins, sending the manufacturer's stock down 9 percent.
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.
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 requesting changes to a device's
label. It discovered deficiencies in the company's previous
mitigation strategy and categorization of 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
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)