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U.S. Department of Health and Human Services

Class 1 Device Recall FreeStyle Flash Blood Glucose Monitors

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  Class 1 Device Recall FreeStyle Flash Blood Glucose Monitors see related information
Date Initiated by Firm February 19, 2014
Date Posted March 18, 2014
Recall Status1 Terminated 3 on August 11, 2015
Recall Number Z-1211-2014
Recall Event ID 67472
510(K)Number K092638  
Product Classification System, test, blood glucose, over the counter - Product Code NBW
Product FreeStyle Blood Glucose Monitors System.
For in vitro diagnostic use only. Store at room
temperature below 86 degrees F (30 degrees C). Use test strips
only within the system operating temperature
range as outlined in your Owner's Booklet.

Meter made in China;
Distributed by Abbott Diabetes Care, Alameda, CA

The FreeStyle mete should only be used with FreeStyle Test Strips and FreeStyle Control Solution. Using other brands of test strips and control solutions with the FreeStyle Mete can product inaccurate results.

The FreeStyle Glucose meter is incorporated into the OmniPod insulin Management system (manufactured by Insulet Corporation, Bedford, MA and is intended for subcutaneous delivery of insulin.

Intended to monitor blood glucose from samples taken from the body. IVD use only,
Code Information Part number CAT11001-0; all serial numbers
Recalling Firm/
Manufacturer		 Abbott Diabetes Care, Inc.
1360 S Loop Rd
Alameda CA 94502-7000
For Additional Information Contact Kelly Duffy
510-749-5400
Manufacturer Reason
for Recall		 Abbott Diabetes Care has identified through internal testing and investigation that all non-applied voltage legacy meters have the potential to produce out of range control solution results and/or erroneously low blood glucose results when used in conjunction with Free Style test strips lots within expiry.
FDA Determined
Cause 2		 Material/Component Contamination
Action The firm, Abbott Diabetes Care, sent an "IMPORTANT: URGENT PRODUCT RECALL"- letter dated February 14, 2014 to all customers for whom they have a record of receiving 0mV meters on February 19, 2014 via trackable method. Abbott also issued Press Release on March 14, 2014. The letter describe the product, problem and actions to be taken. The customers were instructed to discontinue use of your FreeStyle Flash or FreeStyle Blood Glucose Meter and call Abbott Diabetes Care Customer Service at 1-888-345-5364 for replacement at no charge; upon receiving replacement meter; immediately dispose of your old meter in accordance with your local and state disposal regulations; and please read your test strip insert carefully to ensure that you are using the correct test strip type for your Blood Glucose Meter. The firm, OmniPod, sent a ACD letter dated February 7, 2014 and included Abbotts February 14, 2014 letter to its customers. The letter described the product, problem, and actions to be taken. The customers were informed that you can safely continue to use the OmniPod System for your insulin delivery needs. The customers were instructed to read all of the materials included in the Abbott communication carefully and make sure you understand how it affects you; to immediately discontinue use of FreeStyle test strips with the Freestyle meter built into the OmniPod system; call Abbott Diabetes Care Customer Service immediately at 1-877-584-5159 for replacement strips; while waiting on replacement strips, use an unaffected meter such as the FreeStyle Freedom blood glucose meter; you can always use an alternative blood glucose meter. The notification will be posted on the Abbott Diabetes Care website at 222.abbottdiabetescare.com. If you have any further questions, please call Abbott Diabetes Care Customer Service at 1-877-584-5159. For questions or concerns with the continued use of your OmniPod Insulin Management System contact Insulet Product Support at 1-800-591-34
Quantity in Commerce not provided. Device has not been shipped in the last 5 years.
Distribution Worldwide Distribution: US (nationwide) and countries of: Austria, Canada, Germany, Israel, Netherlands, Norway, Sweden, Switzerland, United Kingdom.
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 = ABBOTT DIABETES CARE INC.
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