
Roche Diabetes Care glucose test strips may falsely report elevated blood glucose levels, prompting the FDA to slap the devices with Class 1 recall status, the most serious type of recall that involves situations with a reasonable probability that continued use will cause serious injury or death.
The Roche strips were distributed in France in October 2010 and were never distributed in the U.S.
The company recalled the strips on May 18, 2011, through a French press release informing customers to return any unused inventory of the strips, according to the FDA report.
This is more bad news for the Indianapolis-based company, which recalled its Accu-Chek FlexLink Plus insulin delivery systems in February 2010 over concerns that the tube that delivers the medication can become kinked.