FreeStyle InsuLinx Blood Glucose Monitoring System: For In Vitro… — Class I medical device recall Z-1245-2013
Terminated recall by Abbott Diabetes Care, Inc., reported 2013-05-15, distributed nationwide. AT rare, extremely high glucose levels (1024 mg/dL and above), the FreeStyle InsuLinx Blood Glucose Meter may
| Recall number | Z-1245-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Abbott Diabetes Care, Inc., Alameda, CA, United States |
| Recall initiated | 2013-04-15 |
| Classified | 2013-05-09 |
| Reported by FDA | 2013-05-15 |
| Terminated | 2015-08-03 |
| Distributed | Nationwide (US) |
| Model numbers | 71142-70, 71143-70, 71145-70, 71150-70 |
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 for recall
AT rare, extremely high glucose levels (1024 mg/dL and above), the FreeStyle InsuLinx Blood Glucose Meter may provide an inaccurate reading.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1245-2013. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.