Update on CoaguChek^® Test Strips Sold Through Terrific Care/Medex Supply LLC

February 14, 2019

Background: 
Recently, customers have reported questions and confusion regarding FDA’s recent communication addressing a recall for CoaguChek test strips distributed through Terrific Care/Medex Supply LLC.

To clarify, the CoaguChek XS PT test strips that Roche Diagnostics has been shipping since October 31, 2018 are not affected by this recall and are approved for continued use.  

Roche believes that Terrific Care/Medex Supply imported and distributed CoaguChek test strips that were not labeled or authorized for sale in the United States and, therefore, were not included in Roche's recall. 

• It is our understanding that these CoaguChek XS PT Test Strips were improperly sold to consumers. These test strips included lot numbers that were not listed in Roche Diagnostics’ recall notice issued in November of 2018 because the lots were not authorized or intended to be distributed in the United States. 
• The FDA posted an updated announcement to its website on February 1, 2019 advising customers not to use CoaguChek test strips distributed by Terrific Care/Medex Supply LLC.
• Terrific Care/Medex Supply LLC are not direct business partners with Roche Diagnostics or affiliated companies of Roche Diagnostics.
• Patients and health care providers should immediately stop using CoaguChek XS test strips purchased from Terrific Care/Medex Supply.

All CoaguChek test strips distributed by Roche since October 31st, 2018 are unaffected by any recall.  Roche Diagnostics previously initiated a recall for certain lots of test strips distributed prior to October 31, 2018, and this was communicated in November through Urgent Medical Device Recall notifications from Roche.

Roche's commitment to quality and safety extends beyond our research, development, and manufacturing of our products to the way in which the products are distributed to customers. We are proud to partner with leading, reputable distributors in order to deliver products to our customers in a manner that meets our standards.