Device recall
Z-2138-2014: AdvanDx Quick FISH Fixation Kit for BC ( Blood Cultures), 50 tests. In vitro…
FDA device recall · Class II · Advandx Inc
Key facts
| Recall number (Z-number) | Z-2138-2014 |
|---|---|
| Recall event | 68774 |
| Product | AdvanDx Quick FISH Fixation Kit for BC ( Blood Cultures), 50 tests. In vitro diagnostic. The QuickFISH Fixation Kits are components that are sold separately for the Staphylococcus QuickFISH BC test Catalog number: QFFixBC1-50 (a component for QFSTABC1-50) |
| Product code | NXX |
| Recalling firm | Advandx Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Sep 30, 2014 |
| 510(k) numbers | K113371 |
| FEI number | 3004080598 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 1–9 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