FreeStyle Blood Glucose Test Strips; For in vitro diagnostic testing. 50 count UPC 6 99073 120...
FDA Device Recall #Z-0485-2014 — Class I — November 18, 2013
Recall Summary
| Recall Number | Z-0485-2014 |
| Classification | Class I — Serious risk |
| Date Initiated | November 18, 2013 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Abbott Diabetes Care, Inc. |
| Location | Alameda, CA |
| Product Type | Devices |
| Quantity | 141,219 cartons for human use - all lot numbers |
Product Description
FreeStyle Blood Glucose Test Strips; For in vitro diagnostic testing. 50 count UPC 6 99073 12050 2; Freestyle Blood Glucose Test Strips; for Institutional Use only 50 count: UPC 6 99073 70792 5 Manufactured by Abbott Diabetes Care Inc. Alameda, CA. The FreeStyle Blood Glucose test strip is intended for use in the quantitative measurement of glucose in capillary whole blood from the finger, upper arm and palm. It is intended for use by healthcare professionals and people with diabetes mellitus at home as an aid in monitoring the effectiveness of a diabetes control program. It is not intended for the diagnosis of or screening for diabetes mellitus, and it is not intended for use on neonates or arterial blood.
Reason for Recall
Certain lots of FreeStyle and FreeStyle Lite Blood Glucose Test Strips produce erroneously low blood glucose results when using FreeStyle Blood Glucose Meters, FreeStyle Flash Blood Glucose Meters and the FreeStyle blood glucose meter built into the OmniPod system. Erroneously low results that are not recognized may pose significant risks to your health.
Distribution Pattern
Worldwide Distribution - USA (nationwide and Puerto Rico) and Internationally to Australia, Austria, Belgium, Denmark, Egypt, Finland, France, Germany, Jamaica, Ireland, Israel, United Kingdom, Luxembourg, Netherlands, Norway, Sweden, Switzerland, UAE, and Canada. **Center Recommended Depth - Consumers/User**
Lot / Code Information
Part number 12050-21: Lot number: 1285007 Exp. date: 2014/06; Part number 70792-20 (instuitional use) Lot number: 1373262, Exp. Date 2015/02
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-1022-2026 | Class I | FreeStyle Libre 3 Plus Sensor REF 78769-01 UDI-... | Nov 24, 2025 |
| Z-1021-2026 | Class I | FreeStyle Libre 3 Plus Sensor REF 78768-01 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.