Device recall
Z-1245-2013: FreeStyle InsuLinx Blood Glucose Monitoring System: For In Vitro Diagnostic Use…
FDA device recall · Class I · Abbott Diabetes Care, Inc.
Key facts
| Recall number (Z-number) | Z-1245-2013 |
|---|---|
| Recall event | 64876 |
| 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… |
| Product code | NBW |
| Recalling firm | Abbott Diabetes Care, Inc. |
| Recall class | Class I |
| Status | Terminated |
| Termination date | Aug 3, 2015 |
| 510(k) numbers | K120568 |
| FEI number | 3002803444 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 100–999 Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database