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U.S. Department of Health and Human Services

Class 3 Device Recall OneTouch Ultra Test Strips

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 Class 3 Device Recall OneTouch Ultra Test Stripssee related information
Date Initiated by FirmOctober 19, 2005
Date PostedDecember 08, 2005
Recall Status1 Terminated 3 on July 05, 2006
Recall NumberZ-0273-06
Recall Event ID 33943
510(K)NumberK043197 
Product Classification System, Test, Blood Glucose, Over The Counter - Product Code NBW
ProductLifeScan brand OneTouch Ultra Test strips, 25 strips per vial
Code Information Lot number 2591755, part number 020-245-07
Recalling Firm/
Manufacturer
Lifescan Inc
1000 Gibraltar Dr
Milpitas CA 95035-6301
Manufacturer Reason
for Recall
Vials of OneTouch Ultra Test Strips marked with quantities of 25 per vial actually contain only 10 strips.
FDA Determined
Cause 2
Other
ActionThe firm has issued a letter to distributors, along with a Pass-along letter for notifying sub-distribution consignees, as well as letters for end users and a notification letter on its website.
Quantity in Commerce5799 vials
DistributionProduct was distributed to 9 consignees in NY, KY, MO, AL, TN, LA and IL.
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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