Recall Z-0435-06 ยท CGA Glucose Oxidase, Glucose
Lifescan Inc
LifeScan OneTouch Ultra Test strips, lot number 2528640
| Date | Jan 24, 2006 (initiated Nov 1, 2005) |
| Status | Terminated |
| Reason | Product may be defective and may give low inaccurate glucose results. |
| Root cause | Other |
| Action | Recall was initiated in early November. Notifications were sent on November 21, 2005. The firm has also posted recall notices on its website, and Customer Service Scripting will be available to address questions from callers. |
| Quantity | 7321 boxes of 100 count test strips (29338 vials) |
| Distribution | 7 direct consignees (2 wholesale dealers and 5 distributors_ located in CA, PA, IL, WI, MN, SD, OK, CN, MA, MI. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K043197 | ONETOUCH ULTRA, INDUO AND ULTRASMART BLOOD GLUCOSE MONITORING SYSTEM Lifescan, Inc., May 20, 2005 |