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U.S. Department of Health and Human Services

Class 2 Device Recall LifeScan

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  Class 2 Device Recall LifeScan see related information
Date Initiated by Firm November 17, 2003
Date Posted June 14, 2005
Recall Status1 Terminated 3 on September 20, 2005
Recall Number Z-0887-05
Recall Event ID 32200
510(K)Number K024194  
Product Classification Glucose Oxidase, Glucose - Product Code CGA
Product LifeScan brand OneTouch Ultra Test Strip used in LifeScan Blood Glucose Meter; Part Number 020-244-07; Distributed and Manufactured by: LifeScan, Inc.,
1000 Gibraltar Drive, Milpitas, CA 95037
Code Information OneTouch Ultra Test Strip Lot: 1022859; [A second lot (# 1022865) was also mislabeled with the incorrect Control Solution range. This lot was distributed outside of the US, exclusively in Italy.] 
Recalling Firm/
Manufacturer		 Lifescan Inc
1000 Gibraltar Dr
Milpitas CA 95035-6301
For Additional Information Contact Mario Lowe
408-956-4087
Manufacturer Reason
for Recall		 A Control Solution range for the OneTouch Ultra Test Strip of 111-150 mg/dL was incorrectly labeled as 97-131 mg/dL.
FDA Determined
Cause 2		 Other
Action On 11/17/03 the firm initiated the recall and their notification was via letters informing its customers of the removal.
Quantity in Commerce 8,718 boxes (containing 435,900 test strips)
Distribution Product was released for distribution to 30 consignees nationwide. The firm provided the following distribution information: 6 wholesaler dealers, 20 distributors, 3 retailers and one (1) consumers/users involved in the recall. Note: This customer received a shipment of 2 Test Strip boxes (2 boxes x 50 strips/box = 100 test strips) as 'free goods' and was most likely for an LifeScan employee in the field. The lot was released from LifeScan's facility in Puerto Rico on May 1, 2003 and received at LifeScan's warehouse in Milpitas, CA on May 16, 2003. From the Milpitas warehouse, this lot was transferred to LifeScan's warehouse in Mechanicsburg, PA where it was received on June 16, 2003. The affected lot was distributed out of the Mechanicsburg, PA warehouse only. The recall product was distributed in the U.S. only, to the following states: AL, DE, FL, IL, IN, MA, MI, MN, MO, NC, NH, NJ, OH, PA, TN, TX, VA and WV. (A second lot was also mislabeled with the incorrect Control Solution range. This lot was manufactured outside of the US and distributed exclusively in Italy.) The total number of government sales/distribution centers that received the recall product = 0.
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 = CGA and Original Applicant = LIFESCAN, INC.
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