FreeStyle Blood Glucose Monitors System — Class I medical device recall Z-1211-2014
Terminated recall by Abbott Diabetes Care, Inc., reported 2014-03-26, distributed nationwide. Abbott Diabetes Care has identified through internal testing and investigation that all non-applied voltage le
| Recall number | Z-1211-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Abbott Diabetes Care, Inc., Alameda, CA, United States |
| Recall initiated | 2014-02-19 |
| Classified | 2014-03-18 |
| Reported by FDA | 2014-03-26 |
| Terminated | 2015-08-11 |
| Distributed | Nationwide (US) |
| Countries outside the US | AT, CA, CH, DE, GB, IL, NL, NO, SE |
| Quantity | 5 years |
| Model numbers | 11001-0 |
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,
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1211-2014. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.