Device recall
Z-1103-2008: White Blood Cell (WBC) Reagent-Part A used with the CELL-DYN 4000 and CELL-DYN…
FDA device recall · Class II · Abbott Laboratories
Key facts
| Recall number (Z-number) | Z-1103-2008 |
|---|---|
| Recall event | 46296 |
| Product | White Blood Cell (WBC) Reagent-Part A used with the CELL-DYN 4000 and CELL-DYN Sapphire Systems, Red cell lysing reagent, List Number 01H77-01, Supplied in 3.8L bottles, Abbott Laboratories, Abbott Park, IL 60064 |
| Product code | GGK |
| Recalling firm | Abbott Laboratories |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jul 2, 2008 |
| 510(k) numbers | K051215, K961439 |
| FEI number | 2919069 |
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