Device recall
Z-0880-2015: Alere INRatio PT/INR Test Strips, Alere INRatio PT/INR System Professional…
FDA device recall · Class I · Alere San Diego, Inc.
Key facts
| Recall number (Z-number) | Z-0880-2015 |
|---|---|
| Recall event | 69964 |
| Product | Alere INRatio PT/INR Test Strips, Alere INRatio PT/INR System Professional - 0100071 Alere INRatio PT/INR Test Strips, Box of 12 - 0100139 Alere INRatio PT/INR Test Strips, Box of 48 The test strips are packaged in individually pouched test strips in a labeled box with 12 or 48 test strips per box… |
| Product code | GJS |
| Recalling firm | Alere San Diego, Inc. |
| Recall class | Class I |
| Status | Terminated |
| Termination date | Sep 18, 2017 |
| 510(k) numbers | K020679, K021923, K072727 |
| FEI number | 1000125596 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 10–99 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