Device recall
Z-1051-2017: Great Basin Staph lD/R Blood Culture Panel The Great Basin Staph lD/R Blood…
FDA device recall · Class II · Great Basin Scientific, Inc.
Key facts
| Recall number (Z-number) | Z-1051-2017 |
|---|---|
| Recall event | 76076 |
| Product | Great Basin Staph lD/R Blood Culture Panel The Great Basin Staph lD/R Blood Culture Panel is a qualitative, multiplex in vitro diagnostic assay intended for use with the P4500 PortraitrM Analyzer System. The Staph lD/R Blood Culture Panel is capable of simultaneous detection and identification ol… |
| Product code | PAM |
| Recalling firm | Great Basin Scientific, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Mar 31, 2017 |
| 510(k) numbers | K152470 |
| FEI number | 3009071564 |
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