Drug recall
FreeStyle InsuLinx Blood Glucose Monitoring System: For In Vitro Diagnostic Use only. Use only with FreeStyle…
FDA recall event 64876 · Class I · Abbott Diabetes Care, Inc.
Key facts
| Event ID | 64876 |
|---|---|
| Recall numbers | Z-1245-2013 |
| Recalling firm | Abbott Diabetes Care, Inc. |
| Product type | Devices |
| Products | 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… |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| 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. |
| Initiation date | Apr 15, 2013 |
| Report date | May 15, 2013 |
| Termination date | Aug 3, 2015 |
| City | Alameda |
| State | CA |
| Country | United States |
| FEI number | 3002803444 |
At a glance
- 1–9 Products in this recall
- 10–99 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: