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U.S. Department of Health and Human Services

Class 2 Device Recall One Touch Ultra Test Strips

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  Class 2 Device Recall One Touch Ultra Test Strips see related information
Date Initiated by Firm January 07, 2010
Date Posted October 01, 2010
Recall Status1 Terminated 3 on March 14, 2011
Recall Number Z-2639-2010
Recall Event ID 54382
510(K)Number K062195  
Product Classification System, Test, Blood Glucose, Over The Counter - Product Code NBW
Product One Touch Ultra Test Strips, Part Number 020-245-32, lot number 2964512, Manufactured by LifeScan Inc., Milpitas, CA.
Code Information Part Number 020-245-32, lot number 2964512, manufactured between 09/10/2009 and 09/24/2009, distributed between 09/30/2009 and 10/27/2009.
Recalling Firm/
Manufacturer		 Lifescan Inc
1000 Gibraltar Dr
Milpitas CA 95035
For Additional Information Contact
408-942-5903
Manufacturer Reason
for Recall		 One Touch Ultra Test Strip products may actually contain a different product, One Touch Select strips.
FDA Determined
Cause 2		 Mixed-up of materials/components
Action Notification was issued by the firm during the first week of February. This letter asked consignees to share the information with patients, and are asking users to contact the firm and to examine their stock for the recalled product.
Quantity in Commerce 9631 cartons, 4 vials per carton
Distribution Product was distributed to one wholesale dealer and one distributor and 2 medical facilities in CA, OH and PA, as well as the UK.
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.
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