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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 Device Recall OneTouch Ultra Test stripsee related information
Date Initiated by FirmMarch 22, 2007
Date PostedJuly 13, 2007
Recall Status1 Terminated 3 on August 15, 2008
Recall NumberZ-1042-2007
Recall Event ID 38016
510(K)NumberK062195 
Product Classification Blood Glucose Test Strips - Product Code NBW
ProductOneTouch 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.
FEI Number 2939301
Recalling Firm/
Manufacturer		 Lifescan Inc
1000 Gibraltar Dr
Milpitas CA 95035-6312
For Additional Information ContactThomas 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
ActionMarch 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.
DistributionWorldwide; USA, Europe, Middle East, Africa, Latin America and Canada.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = NBW
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