Device recall
Z-1211-2014: FreeStyle Blood Glucose Monitors System. For in vitro diagnostic use only. Store…
FDA device recall · Class I · Abbott Diabetes Care, Inc.
Key facts
| Recall number (Z-number) | Z-1211-2014 |
|---|---|
| Recall event | 67472 |
| Product | FreeStyle Blood Glucose Monitors System. For in vitro diagnostic use only. Store at room temperature below 86 degrees F (30 degrees C). Use test strips only within the system operating temperature range as outlined in your Owner's Booklet. Meter made in China; Distributed by Abbott Diabetes Care… |
| Product code | NBW |
| Recalling firm | Abbott Diabetes Care, Inc. |
| Recall class | Class I |
| Status | Terminated |
| Termination date | Aug 11, 2015 |
| 510(k) numbers | K092638 |
| 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