Recall Z-1211-2014 ยท NBW System, Test, Blood Glucose, Over The Counter
Abbott Diabetes Care, Inc.
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
| Date | Mar 18, 2014 (initiated Feb 19, 2014) |
| Status | Terminated |
| Reason | 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. |
| Root cause | 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 you |
| Quantity | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K092638 | FREESTYLE BLOOD GLUCOSE TEST STRIPS, MODELS 100-COUNT: 12401-01, 12101-21, 12101-22, 12101-23 Abbott Diabetes Care, Inc., Jun 15, 2010 |