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U.S. Department of Health and Human Services

Class 2 Device Recall OneTouch Ultra Test strip

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 Class 2 Recall
OneTouch Ultra Test strip
see related information
Date Posted July 13, 2007
Recall Status1 Terminated on August 15, 2008
Recall Number Z-1042-2007
Recall Event ID 38016
Premarket Notification
510(K) Number
K062195 
Product Classification System, Test, Blood Glucose, Over The Counter - 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, California 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
DESIGN: Device Design
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

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = NBW and Original Applicant = LIFESCAN, INC.
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