FDA Gives Medical Devices Recall its Most Serious Designation
February 01 2019 - 4:29PM
Dow Jones News
By Patrick Thomas
The U.S. Food and Drug Administration said Friday that it is
issuing its most serious type of recall classification for medical
devices distributed by Terrific Care LLC and Medex Supply LLC.
The two device distributors issued a voluntary recall in
December of certain Roche Diagnostics test strip lots used in its
CoaguChek test meter devices. The company is a subsidiary of Roche
Holdings Ltd. RHHBY).
The FDA's recall classification on Friday means that use of the
devices may cause serious injuries or death.
Roche initially recalled its CoaguChek meters and test strips in
November, which included more than 1.1 million devices that were
distributed nationwide from Jan. 2018 to the end of October.
The December recall by Terrific Care and Medex Supply had
devices that weren't included in Roche's November action because
the test strips weren't labeled or authorized for sale in the U.S.,
the FDA said. Terrific Care and Medex Supply purchased the test
strips from an unknown source and imported and sold them in the
U.S., the agency said.
Representatives from Terrific Care and Medex Supply didn't
immediately respond to requests for comment.
Write to Patrick Thomas at patrick.thomas@wsj.com
(END) Dow Jones Newswires
February 01, 2019 16:14 ET (21:14 GMT)
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