FreeStyle InsuLinx Blood Glucose Monitoring System: For In Vitro Diagnostic Use only. Use only w...
FDA Device Recall #Z-1245-2013 — Class I — April 15, 2013
Recall Summary
| Recall Number | Z-1245-2013 |
| Classification | Class I — Serious risk |
| Date Initiated | April 15, 2013 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Abbott Diabetes Care, Inc. |
| Location | Alameda, CA |
| Product Type | Devices |
| Quantity | 335,273 meters; 209,336 remain at firm. |
Product Description
FreeStyle InsuLinx Blood Glucose Monitoring System: For In Vitro Diagnostic Use only. Use only with FreeStyle InsuLinx test strips. Abbott Diabetes Care, Inc. 1360 South Loop Road Alameda, CA 94502 USA The FreeStyle InsuLinx Blood Glucose Test Strips are for use with the FreeStyle InsuLinx Blood Glucose Meter to quantitatively measure glucose in capillary whole blood samples drawn from the fingertip.
Reason for Recall
AT rare, extremely high glucose levels (1024 mg/dL and above), the FreeStyle InsuLinx Blood Glucose Meter may provide an inaccurate reading.
Distribution Pattern
Nationwide Distribution
Lot / Code Information
Part Numbers: 71142-70 71143-70 71145-70 71150-70: All serial and lot 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-1023-2026 | Class I | FreeStyle Libre 3 Plus Sensor REF 72080-01 UDI-... | 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-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.