BAYER HEALTHCARE RECALLS 10-COUNT and 25-COUNT VIALS OF BLOOD GLUCOSE TEST STRIPS IN UNITED STATES
US Action Follows Stop-Ship That Began in June
Tarrytown, NY --Bayer HealthCare confirmed today that it is recalling all 10- and 25- count Contour strips and 10-count Contour TS test strips from US retail stocks, retail distribution channels and offices of US healthcare professionals. The FDA is aware of this action.
These actions are not taken as a result of any adverse events reported to Bayer. Instead, Bayer is taking this action out of an abundance of caution to address a packaging issue which, under certain conditions, can cause some test strips packaged in some small-count vials to operate outside of US FDA-cleared performance specifications and produce a low-bias reading during blood glucose testing. In the FDA’s view, this deviation from US-approved specifications constituted a technical violation that required a field corrective action under US regulations.
50-count vials of Contour test strips are not affected, and strips used with Bayer’s Breeze™2 blood glucose meters are not affected.
This action follows Bayer’s decision in late June to stop new shipments of products containing the small-count vials of these test strips world-wide. And with no new shipments of small count vials into the market since that time, we believe remaining unused quantities of potentially affected product in the market are likely very small.
While it resolves this issue, Bayer has increased its stocks of 50-count vials and is using these to fulfill new orders to ensure continued, uninterrupted market access to unaffected strips.