| |
Class 1 Device Recall LifeScan |
 |
| Date Initiated by Firm |
April 11, 2005 |
| Date Posted |
May 17, 2005 |
| Recall Status1 |
Terminated 3 on January 24, 2007 |
| Recall Number |
Z-0823-05 |
| Recall Event ID |
31640 |
| 510(K)Number |
K024194
|
| Product Classification |
System, Test, Blood Glucose, Over The Counter - Product Code NBW
|
| Product |
LifeScan Brand InDuo Blood Glucose Meter |
| Code Information |
ALL CODES: All lot numbers and serial numbers |
Recalling Firm/
Manufacturer |
Lifescan Inc
1000 Gibraltar Dr
Milpitas CA 95035-6301
|
| For Additional Information Contact |
Mario Lowe
408-956-4087
|
Manufacturer Reason
for Recall |
User may inadvertently change the Units of Measure from mg/dL to mmol/L and the blood glucose results could be misinterpreted. This may lead to under treatment and potential for hyperglycemia.
|
FDA Determined
Cause 2 |
Other |
| Action |
On 4/11/05, the firm issued letters via Federal Express to all its direct consignees, informing them of the affected products and providing instructions on the correction.
Owner's booklet: Firm contacted all accounts by letters of 11/21/03, 2/4/2004, 2/17/04 and 2/9-10/2004 providing important information regarding the owner's booklet. |
| Distribution |
Distribution of the product is worldwide. ***Distribution in the United States was between January 15, 2001 for OneTouch Ultra Blood Glucose Meter; April 13, 1998 for OneTouch FastTake Blood Glucose Meter and November 30, 2001 for InDuo Blood Glucose Meter.***
The total number of quantities shipped to consignees is approx. 1.8 Million. Of these,
Approx. 282,000 were shipped to Pharmacies and Healthcare Professionals (including Diabetes Educators, Primary Care Physicians, Endocrinologists), Approx. 800 were shipped to Mail Order companies that distribute OneTouch ¿ FastTake¿ and OneTouch ¿ Ultra¿ products, and Approx. 130,000 were shipped to E-mail End User Notifications to LifeScan database of OneTouch¿ Ultra¿, OneTouch¿ FastTake¿ and InDuo¿ product users.
Ultra, InDuo, FastTake Meters Global Distribution include:
Algeria,
Argentina,
Australia,
Austria,
Bahrain,
Belgium,
Brazil,
Canada,
Caribbean,
CEE,
Chile,
China,
Columbia,
Croatia,
Czech Republic,
Denmark,
Ecuador,
Egypt,
Finland,
France,
Georgia,
Germany,
Greece,
Hong Kong,
India,
Indonesia,
Israel,
Italy,
Japan,
Jordan,
Kazakhstan,
Korea,
Kuwait,
Latin America,
Latin America,
Lebanon,
Malaysia,
Malta,
MEA,
Mexico,
Netherlands,
Norway,
Oman,
Pasean,
Peru,
Philippines,
Poland,
Portugal,
Qatar,
Russia,
Saudi Arabia/Gulf Countries,
Singapore,
Slovakia,
Slovenia,
South Africa,
Spain,
Sub-Saharan Africa,
Sweden,
Switzerland,
Taiwan,
Thailand,
Tunisia,
Turkey,
Ukraine,
United Arab Emirates,
United Kingdom,
United States,
Uruguay,
Venezuela,
Vietnam, and
Yemen.
Owner's booklet: The recall product was distributed in the U.S. only.
LifeScan manufactured and distributed OneTouch Ultra System Kits with the affected OneTouch Ultra Meter Owner's Booklets between March 31, 2003 and October 3, 2003.
|
| Total Product Life Cycle |
TPLC Device Report
|
|
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
|
| 510(K) Database |
510(K)s with Product Code = NBW and Original Applicant = LIFESCAN, INC.
|
|
|
|
