Device recall
Z-0619-2014: AdvanDx Gram-Negative QuickFISH BC. In-Vitro Diagnostic for the identification…
FDA device recall · Class III · AdvanDx, Inc.
Key facts
| Recall number (Z-number) | Z-0619-2014 |
|---|---|
| Recall event | 67069 |
| Product | AdvanDx Gram-Negative QuickFISH BC. In-Vitro Diagnostic for the identification of Enterobacteriacae Catalog Number: QFGNRBC1-25 Gram-Negative QuickFISH BC provides rapid identification of Escherichia coli, and/or Pseudomonas aeruginosa, and/or Klebsiella pneumoniae directly from GNR-positive blood… |
| Product code | JSS |
| Recalling firm | AdvanDx, Inc. |
| Recall class | Class III |
| Status | Terminated |
| Termination date | Jan 13, 2014 |
| 510(k) numbers | K123418 |
| 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