Recall Z-0101-06 ยท CGA Glucose Oxidase, Glucose
Lifescan Inc
Lifescan OneTouch SureStep Meter Blood Glucose monitoring system,Product is distributed by LifeScan, Inc., 1000 Gibraltar Dr., Milpitas, CA 95037
| Date | Oct 28, 2005 (initiated Sep 9, 2005) |
| Status | Terminated |
| Reason | The LCD of the OneTouch SureStep Meter may display incorrectly, resulting in missing segments on the display. This display failure may result in patients misreading the blood glucose result, or cause a delay in test interpretation, and could cause delays or mistreatment. |
| Root cause | Other |
| Action | On 9/9/05, ***and 4/14/06 (expanded)***the firm notified its consumers, Health Care Professionals (HCPs), pharmacies, and direct accounts (including wholesalers and distributors) by letter and phone calls. |
| Quantity | 19,177 meters were distributed in the U.S., with 29,377 distributed abroad, to Asia, Europe and Latin America. |
| Distribution | Total amount of product distributed in the U.S. is 19,177 units, to distribution centers to be distributed to retailers, Health Care Professionals, wholesalers, and mail order companies. The product was distributed throughout the United States; 29,377 were distributed to Asia, Europe and Latin Am |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K023832 | SURESTEP HOSPITAL BLOOD GLUCOSE MONITORING SYSTEM Lifescan, Inc., Dec 13, 2002 |