Date Initiated by Firm |
March 22, 2007 |
Date Posted |
July 13, 2007 |
Recall Status1 |
Terminated 3 on August 15, 2008 |
Recall Number |
Z-1042-2007 |
Recall Event ID |
38016 |
510(K)Number |
K062195
|
Product Classification |
Blood Glucose Test Strips - Product Code NBW
|
Product |
OneTouch Ultra Test strip, a component of the following OneTouch Ultra Glucose monitoring systems: a)OneTouch Ultra, b) OneTouch InDuo, c) OneTouch Ultra2, d) OneTouch UltraMini, e) OneTouch UltraSmart. 25 strips per vial. Product comes in packs of 100 and 50. (Part numbers: 020-245-07, 020-244-07, 020-963-01) |
Code Information |
Part numbers 020-245-07 (100 pack), 020-244-07 (50 pack), 020-963-01 (50 pack mail order). Expiration dates 08/2007 through 11/2008. |
Recalling Firm/ Manufacturer |
Lifescan Inc 1000 Gibraltar Dr Milpitas CA 95035-6312
|
For Additional Information Contact |
Thomas A. West 408-586-5461
|
Manufacturer Reason for Recall |
Damaged Vials/Inaccurate test results: a manufacturing equipment problem on one of the packaging lines had the potential to puncture vials, causing a single hole in the side of the vial below the rim. This result of this defect may produce inaccurately high or low blood glucose test results or error message readings.
|
FDA Determined Cause 2 |
Other |
Action |
March 2007 via letters to consumers and consignees and web postings. The firm has also set up verbal communication plans for customers who contact Lifescan by phone. |
Quantity in Commerce |
~33 million vials (25 strips per vial in the US, ~19 million worldwide. |
Distribution |
Worldwide; USA, Europe, Middle East, Africa, Latin America and Canada. |
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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