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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 Recall
One Touch Ultra Test Strips
see related information
Date Posted October 01, 2010
Recall Status1 Terminated on March 14, 2011
Recall Number Z-2639-2010
Recall Event ID 54382
Premarket Notification
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, California 95035
Manufacturer Reason
for Recall
One Touch Ultra Test Strip products may actually contain a different product, One Touch Select strips.
FDA Determined
Cause 2
COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Mix-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 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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