Lifescan OneTouch SureStep Meter Blood Glucose monitoring system,Product is distributed by LifeScan, Inc., 1000 Gibraltar Dr., Milpitas, CA 95037
FDA Recall Z-0101-06 · Posted 2005-10-28
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Recalling FirmLifescan Inc
Recall StatusTerminated
Product CodeCGA
Date Initiated2005-09-09
Date Terminated2006-12-18
Product Quantity19,177 meters were distributed in the U.S., with 29,377 distributed abroad, to Asia, Europe and Latin America.
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.
Firm Action
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
Distribution Pattern
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 was distributed throughout the United States; 29,377 were distributed to Asia, Europe and Latin America.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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