Device recall
Z-0301-2008: Abbott Diagnostics CELL-DYN Sapphire Hemoglobin Reagent Analyzer Syringes, List…
FDA device recall · Class II · Abbott Laboratories
Key facts
| Recall number (Z-number) | Z-0301-2008 |
|---|---|
| Recall event | 45446 |
| Product | Abbott Diagnostics CELL-DYN Sapphire Hemoglobin Reagent Analyzer Syringes, List Number 08H49-02, Abbott Laboratories, Abbott Park, IL (the syringe is packaged in a white box and sealed with a label wrapped around the center of the box-The main analyzer list number is 08H00-01, ) |
| Product code | GKZ |
| Recalling firm | Abbott Laboratories |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Nov 17, 2009 |
| 510(k) numbers | K051215 |
| FEI number | 2919069 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 100–999 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