FDA Device recall Z-1245-2013
FreeStyle InsuLinx Blood Glucose Monitoring System: For In Vitro Diagnostic Use only
- FDA Device
- Class I
- terminated
- Published 2013-05-15
On 2013-05-15 the FDA classified a Class I recall of FreeStyle InsuLinx Blood Glucose Monitoring System: For In Vitro Diagnostic Use only by Abbott Diabetes Care, citing AT rare, extremely high glucose levels (1024 mg/dL and above), the FreeStyle InsuLinx Blood Glucose Meter may provide an inaccurate reading.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1245-2013 |
| Classification | Class I |
| Status | terminated |
| Initiated | 2013-04-15 |
| Published | 2013-05-15 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Abbott Diabetes Care |
| Distribution | US |
Product
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
AT rare, extremely high glucose levels (1024 mg/dL and above), the FreeStyle InsuLinx Blood Glucose Meter may provide an inaccurate reading.
Identifiers
| code_info | Part Numbers: 71142-70 71143-70 71145-70 71150-70: All serial and lot numbers. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Other recalls by Abbott Diabetes Care
- FreeStyle Libre 3 Plus Sensor REF 78768-01 UDI-DI code: 00357599844011 The FreeStyle Libre 3 Plus sensor is a component of the FreeStyle Li…
FDA Device · Class I · 2026-01-21 · Abbott Diabetes Care - FreeStyle Libre 3 Sensor REF 72081-01 UDI-DI code: 00357599818005 The FreeStyle Libre 3 sensor is a component of the FreeStyle Libre 3 Cont…
FDA Device · Class I · 2026-01-21 · Abbott Diabetes Care - FreeStyle Libre 3 Plus Sensor REF 72080-01 UDI-DI code: 00357599819002 The FreeStyle Libre 3 Plus sensor is a component of the FreeStyle Li…
FDA Device · Class I · 2026-01-21 · Abbott Diabetes Care - FreeStyle Libre 3 Plus Sensor REF 78769-01 UDI-DI code: 00357599843014 The FreeStyle Libre 3 Plus sensor is a component of the FreeStyle Li…
FDA Device · Class I · 2026-01-21 · Abbott Diabetes Care - FreeStyle Libre 3 Sensors, REF: 72081-01, component of the FreeStyle Libre 3 Continuous Glucose Monitoring System
FDA Device · Class I · 2024-09-04 · Abbott Diabetes Care
All Abbott Diabetes Care recalls
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1245-2013%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.