Lifescan OneTouch SureStep Meter Blood Glucose monitoring system,Product is distributed by LifeScan, Inc., 1000 Gibralta
FDA device recall Z-0101-06 · posted 2005-10-28 · Terminated
Recall details
- Recalling firm
- Lifescan Inc
- Reason for recall
- 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.
- Action taken
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- CGA
- Quantity affected
- 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 w
- Date initiated
- 2005-09-09
- Date posted
- 2005-10-28
- Date terminated
- 2006-12-18
- Location
- Milpitas, CA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SURESTEP HOSPITAL BLOOD GLUCOSE MONITORING SYSTEM (K023832) | Lifescan, Inc. | 2002-12-13 |