LifeScan brand OneTouch Ultra Test Strip used in LifeScan Blood Glucose Meter; Part Number 020-244-07; Distributed and M
FDA device recall Z-0887-05 · posted 2005-06-14 · Terminated
Recall details
- Recalling firm
- Lifescan Inc
- Reason for recall
- A Control Solution range for the OneTouch Ultra Test Strip of 111-150 mg/dL was incorrectly labeled as 97-131 mg/dL.
- Action taken
- On 11/17/03 the firm initiated the recall and their notification was via letters informing its customers of the removal.
- Root cause
- Other
- Status
- Terminated
- Product code
- CGA
- Quantity affected
- 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/us
- Date initiated
- 2003-11-17
- Date posted
- 2005-06-14
- Date terminated
- 2005-09-20
- Location
- Milpitas, CA
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ONE TOUCH ULTRA AND ONE TOUCH INDUO BLOOD GLUCOSE MONITORING SYSTEMS (K024194) | Lifescan, Inc. | 2003-02-07 |