Date Initiated by Firm |
November 25, 2008 |
Date Posted |
March 17, 2009 |
Recall Status1 |
Terminated 3 on December 06, 2010 |
Recall Number |
Z-1070-2009 |
Recall Event ID |
50471 |
510(K)Number |
K022724
|
Product Classification |
Over the Counter Blood Glucose Test System - Product Code NBW
|
Product |
OneTouch SureStep Test Strips, Part numbers 020-052-01 and 010-359-04, for use with SureStep brand Blood Glucose Meters, manufactured by LifeScan Inc., Milpitas, CA |
Code Information |
Lot codes 2802961 and 2802962 |
Recalling Firm/ Manufacturer |
Lifescan Inc 1000 Gibraltar Dr Milpitas CA 95035
|
For Additional Information Contact |
408-942-5903
|
Manufacturer Reason for Recall |
Deformity in the test strip may result in insufficient blood transfer to reaction area, resulting in inaccurate test results.
|
FDA Determined Cause 2 |
Process design |
Action |
Urgent: Medical Device Recall letters, dated 11/24/2008 were issued to all consignees on November 25, 2008, requesting return of affected lots to LifeScan and instructing how to obtain replacement strips free of charge. A request for sub-recall communications were made as well, and the firm posted notification on its website. Customer service and Sales account reps were provided information to address questions regarding the recall. |
Quantity in Commerce |
23,288 vials |
Distribution |
Worldwide Distribution -- USA and the Caribbean. |
Total Product Life Cycle |
TPLC Device Report
|
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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.
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