Recall Z-0453-2007 ยท CGA Glucose Oxidase, Glucose
Lifescan Inc
LifeScan brand One Touch -Sure Step Pro- Blood Glucose Monitoring System Test Strips, 50 strips per package, Distributed and Manufactured by: LifeScan, Inc., 1000 Gibraltar Drive, Milpitas, CA 95037
| Date | Jan 5, 2007 (initiated Sep 29, 2006) |
| Status | Terminated |
| Reason | Inaccurage test results: testing may lead to no test results, error message or inaccurately low test results. |
| Root cause | Other |
| Action | The firm has issued notification on 9/29/06 to consumers and hospital end users known to the firm and direct accounts that received the recalled product. The firm also posted the notice on the website, and customer service scripting was developed to notify callers. |
| Quantity | 26,398 units (both recall numbers Z-0452/3-2007 |
| Distribution | Nationwide to Al, AZ, CA, CN, DE, FL, GA, IL, IN, KT, KY, LA, MA, MD, MI, MN, MS, MO, NE, NJ, NM, and TX. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K023194 | SURESTEPPRO/SURESTEPFLEXX PROFESSIONAL BLOOD GLUCOSE MANAGEMENT SYSTEM Lifescan, Inc., Oct 24, 2002 |