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 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

Recall number

Z-1211-2014

Recalling firm

Abbott Diabetes Care, Inc.

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,

Status

Terminated

Initiated

2014-02-19

Posted

2014-03-18

Terminated

2015-08-11

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 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

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.

Lot, serial or model codes

Part number CAT11001-0; all serial numbers

510(k) numbers

["K092638"]

PMA numbers

not on file

Product code

NBW

Firm FEI

3002803444

Firm city

Alameda

Firm state

CA

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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