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FreeStyle Blood Glucose Monitors System recallZ-1211-2014 · Abbott Diabetes Care, Inc. · initiated Feb 19, 2014

Class I Terminated All recalls posted in March 2014

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Abbott Diabetes Care, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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 root cause category: Material/Component Contamination

What the company is doing

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

Recall details

Recall number
Z-1211-2014
Recall class
Class I (most serious)
Status
Terminated
Initiated by the company
Feb 19, 2014
Posted by the FDA
Mar 18, 2014
Recalling firm
Abbott Diabetes Care, Inc.
Quantity
not provided. Device has not been shipped in the last 5 years.
Product code
NBW
FDA submissions
K092638
Distribution
Worldwide Distribution: US (nationwide) and countries of: Austria, Canada, Germany, Israel, Netherlands, Norway, Sweden, Switzerland, United Kingdom.

Product description

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 (models, lots, serial numbers)

Part number CAT11001-0; all serial numbers

Other devices under the same FDA submission

3 devices cleared under K092638 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Other products in the same recall event

The FDA groups related products into one recall event (event 67472).

Sources and updates

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