FreeStyle Flash Blood Glucose Monitors System. Meter made in China; Distributed by TheraSen...

FDA Device Recall #Z-1212-2014 — Class I — February 19, 2014

Recall Summary

Recall Number Z-1212-2014
Classification Class I — Serious risk
Date Initiated February 19, 2014
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Abbott Diabetes Care, Inc.
Location Alameda, CA
Product Type Devices
Quantity 25,203 units

Product Description

FreeStyle Flash Blood Glucose Monitors System. Meter made in China; Distributed by TheraSense, Alameda, CA The FreeStyle Flash meter should only be used with FreeStyle Test Strips and FreeStyle Control Solution. Using other brands of test strips and control solutions with the FreeStyle Meter can product inaccurate results. 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.

Distribution Pattern

Worldwide Distribution: US (nationwide) and countries of: Austria, Canada, Germany, Israel, Netherlands, Norway, Sweden, Switzerland, United Kingdom.

Lot / Code Information

Catalog Number 17002 NDC 99073-0170-02. All serial numbers

Other Recalls from Abbott Diabetes Care, Inc.

Recall # Classification Product Date
Z-1020-2026 Class I FreeStyle Libre 3 Sensor REF 72081-01 UDI-DI co... Nov 24, 2025
Z-1021-2026 Class I FreeStyle Libre 3 Plus Sensor REF 78768-01 UDI-... Nov 24, 2025
Z-1022-2026 Class I FreeStyle Libre 3 Plus Sensor REF 78769-01 UDI-... Nov 24, 2025
Z-1023-2026 Class I FreeStyle Libre 3 Plus Sensor REF 72080-01 UDI-... Nov 24, 2025
Z-2692-2024 Class I FreeStyle Libre 3 Sensors, REF: 72081-01, compo... Jul 24, 2024

Frequently Asked Questions

Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.

Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.

Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.

What Should You Do?

Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.