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)

Copyright (c) 2019 Dow Jones & Company, Inc.
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