Recall Z-0887-05 ยท CGA Glucose Oxidase, Glucose
Lifescan Inc
LifeScan brand OneTouch Ultra Test Strip used in LifeScan Blood Glucose Meter; Part Number 020-244-07; Distributed and Manufactured by: LifeScan, Inc., 1000 Gibraltar Drive, Milpitas, CA 95037
| Date | Jun 14, 2005 (initiated Nov 17, 2003) |
| Status | Terminated |
| Reason | A Control Solution range for the OneTouch Ultra Test Strip of 111-150 mg/dL was incorrectly labeled as 97-131 mg/dL. |
| Root cause | Other |
| Action | On 11/17/03 the firm initiated the recall and their notification was via letters informing its customers of the removal. |
| Quantity | 8,718 boxes (containing 435,900 test strips) |
| Distribution | Product was released for distribution to 30 consignees nationwide. The firm provided the following distribution information: 6 wholesaler dealers, 20 distributors, 3 retailers and one (1) consumers/users involved in the recall. Note: This customer received a shipment of 2 Test Strip boxes (2 boxes |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K024194 | ONE TOUCH ULTRA AND ONE TOUCH INDUO BLOOD GLUCOSE MONITORING SYSTEMS Lifescan, Inc., Feb 7, 2003 |