Recall Z-1212-2014
Abbott Diabetes Care, Inc. · initiated February 19, 2014
Class I – dangerous or defective products that could cause serious health problems or death
Product
FreeStyle Flash Blood Glucose Monitors System. Meter made in China; Distributed by TheraSense, Alameda, CA The FreeStyle Flash meter should only be used with FreeStyle Test Strips and FreeStyle Control Solution. Using other brands of test strips and control solutions with the FreeStyle Meter can product inaccurate results. Intended to monitor blood glucose from samples taken from the body. IVD use only,
Codes / lots: Catalog Number 17002 NDC 99073-0170-02. All serial numbers
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: Material/Component Contamination
Action taken
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
Details
- Recall number
- Z-1212-2014
- Initiated
- February 19, 2014
- Posted by FDA
- March 18, 2014
- Terminated
- August 11, 2015
- Product code
- NBW – System, Test, Blood Glucose, Over The Counter
- Quantity
- 25,203 units
- Distribution
- Worldwide Distribution: US (nationwide) and countries of: Austria, Canada, Germany, Israel, Netherlands, Norway, Sweden, Switzerland, United Kingdom.
- Recalling firm
- Abbott Diabetes Care, Inc., Alameda, CA
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-1211-2014 Class I | FreeStyle Blood Glucose Monitors System. For in vitro diagnostic use only. Store at room…Abbott Diabetes Care has identified through internal testing and investigation that all non-applied voltage… | 02/19/2014Terminated |