CLASS I Device recall · Reported 26 Mar 2014 · FDA Enforcement Report
FreeStyle Blood Glucose Monitors System recalled by Abbott Diabetes Care
Abbott Diabetes Care is recalling FreeStyle Blood Glucose Monitors System, distributed nationwide in the US. The recall was initiated on 19 Feb 2014 and the FDA has classified it as Class I.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1211-2014
- FDA event ID
- 67472
- Recalling firm
- Abbott Diabetes Care, Alameda, CA
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- 19 Feb 2014
- FDA classified
- 18 Mar 2014
- Reported
- 26 Mar 2014
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Labeling Errors
- Device type
- Insulin Pumps & Glucose Monitors
Timeline
| 19 Feb 2014 | Recall initiated by company | |
| 18 Mar 2014 | Classified by FDA | +27 days |
| 26 Mar 2014 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Product as listed by the FDA
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,
Where it was distributed
Worldwide Distribution: US (nationwide) and countries of: Austria, Canada, Germany, Israel, Netherlands, Norway, Sweden, Switzerland, United Kingdom.
Questions about this recall
Is FreeStyle Blood Glucose Monitors System recalled?
Yes. Abbott Diabetes Care recalled FreeStyle Blood Glucose Monitors System on 19 Feb 2014. The recall is Class I and its status is Terminated. Recall number Z-1211-2014.
Why was it 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.
Which lots are affected?
Part number CAT11001-0; all serial numbers
Where was it sold?
Worldwide Distribution: US (nationwide) and countries of: Austria, Canada, Germany, Israel, Netherlands, Norway, Sweden, Switzerland, United Kingdom.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class I mean?
Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Abbott Diabetes Care
All 13| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | FreeStyle Libre 3 App, part of Continuous Glucose recalled | Abbott Diabetes Care | Lead & Heavy Metals | Nationwide |
| Device | CLASS II | FreeStyle Libre 2 Readers recalled by Abbott Diabetes Care | Abbott Diabetes Care | Device Malfunction | Nationwide |
| Device | CLASS I | FreeStyle Libre Reader recalled by Abbott Diabetes Care | Abbott Diabetes Care | Device Malfunction | Nationwide |
| Device | CLASS I | FreeStyle Libre Reader recalled by Abbott Diabetes Care | Abbott Diabetes Care | Device Malfunction | Nationwide |
| Device | CLASS I | FreeStyle Libre Reader recalled by Abbott Diabetes Care | Abbott Diabetes Care | Device Malfunction | Nationwide |
Other Insulin Pumps & Glucose Monitors recalls
All 459| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | MiniMed Insulin Pump recalled by Medtronic MiniMed | Medtronic MiniMed | Other | Nationwide |
| Device | CLASS II | MiniMed Insulin Pump recalled by Medtronic MiniMed | Medtronic MiniMed | Other | Nationwide |
| Device | CLASS II | MiniMed Insulin Pump recalled by Medtronic MiniMed | Medtronic MiniMed | Other | Nationwide |
| Device | CLASS II | MiniMed Insulin Pump recalled by Medtronic MiniMed | Medtronic MiniMed | Lead & Heavy Metals | Nationwide |
| Device | CLASS I | Omnipod (Eros) Pod recalled by Insulet | Insulet | Lead & Heavy Metals | Nationwide |