Recall Z-3268-2011 ยท LFR Glucose Dehydrogenase, Glucose
Bayer Healthcare, LLC
Contour, Contour TS Blood Glucose Test Strips and Bonus Packs Intended for self-testing by people with diabetes and healthcare professionals to monitor glucose concentrations in whole blood
| Date | Sep 19, 2011 (initiated Aug 12, 2011) |
| Status | Terminated |
| Reason | All 10- or 25- count glucose test strip vials, either loose vials or found in patient starter kits of Contour, Contour TS and Contour" USB blood glucose meters are being recalled 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 |
| Root cause | Packaging |
| Action | Bayer sent an "URGENT DIABETES TEST STRIP RECALL" letter dated August 12, 2011, to its customers with the name of the test strips, sizes recalled, reason for the recall, potential injury, and instructions to discontinue use and return the test strips to Bayer. The recall letter also included a recall response form that was to be faxed back to Bayer at 1-800-876-2243. For questions call Customer Logistics at 1-800-348-2637. |
| Quantity | 3,617,287 vials/ 54,555,460 test strips |
| Distribution | Nationwide Distribution and Puerto Rico |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K062058 | ASCENSIA CONTOUR BLOOD GLUCOSE METER, MODEL 7151; REAGENT STRIP, MODEL 7080 Bayer Healthcare, Sep 11, 2006 |