| Class 2 Device Recall LifeScan OneTouch Select Control Solution | |
Date Initiated by Firm | February 25, 2013 |
Date Posted | April 17, 2013 |
Recall Status1 |
Terminated 3 on October 23, 2013 |
Recall Number | Z-1130-2013 |
Recall Event ID |
64478 |
510(K)Number | K072543 |
Product Classification |
Single (specified) analyte controls (assayed and unassayed) - Product Code JJX
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Product | LifeScan brand OneTouch Select Control Solution, Part Number/Model #: 02168902.
Testing of Blood Glucose Levels. |
Code Information |
2AA2101, Exp. Date: 9-30-2014; 2AA2102, Exp. Date: 10-31-2-14 |
Recalling Firm/ Manufacturer |
Lifescan Inc 1000 Gibraltar Dr Milpitas CA 95035-6301
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For Additional Information Contact | Mr. Jon Mulberg 408-942-5903 |
Manufacturer Reason for Recall | When OneTouch Ultra and OneTouch Select test strips are tested with Ultra and Select control solution the meter may display a result outside the control solution test range printed on the strip vial label even though the system is working properly. |
FDA Determined Cause 2 | Nonconforming Material/Component |
Action | LifeScan sent an "URGENT MEDICAL DEVICE RECALL" letter dated February 25, 2013 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. Customers may contact OneTouch Healthcare Professional Line at 866-461-0089 for questions about this notice. |
Quantity in Commerce | 132,301 units total |
Distribution | Worldwide Distribution-USA (nationwide) including DC and Puerto Rico and the states of AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, 10, IL, IN, KS, KY, LA, MA, MD, ME, Ml, MN, MO, MS, MT, NC, NO, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SO, TN, TX, UT, VA, VI, VT, WA, WI,WV, and WY, and the countries of Russia and Ukraine. |
Total Product Life Cycle | TPLC Device Report |
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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.
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510(K) Database | 510(K)s with Product Code = JJX
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