Device recall
Z-0278-04: Package Insert for TDx/TDxFLx and TDxFLx Gentamicin Reagents, REF 9512, item…
FDA device recall · Class II · Abbott Laboratories HPD/ADD/GPRD
Key facts
| Recall number (Z-number) | Z-0278-04 |
|---|---|
| Recall event | 27780 |
| Product | Package Insert for TDx/TDxFLx and TDxFLx Gentamicin Reagents, REF 9512, item numbers 34-1074/R3 and 69-5120/R2; Abbott Laboratories, Diagnostics Division, Abbott Park, IL 60064 |
| Product code | LCD |
| Recalling firm | Abbott Laboratories HPD/ADD/GPRD |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Nov 1, 2004 |
| 510(k) numbers | K840826, K871645 |
| FEI number | 1415939 |
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