Device recall
Z-2770-2016: Fluorocell PLT reagent, Catalog #CD994563 Fluorocell PLT is used to stain…
FDA device recall · Class II · Sysmex America Inc
Key facts
| Recall number (Z-number) | Z-2770-2016 |
|---|---|
| Recall event | 74654 |
| Product | Fluorocell PLT reagent, Catalog #CD994563 Fluorocell PLT is used to stain platelets in a diluted blood sample for the counting of platelets with the Sysmex XN-Series automated hematology analyzers |
| Product code | KQC |
| Recalling firm | Sysmex America Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Feb 10, 2017 |
| FEI number | 3009711478 |
At a glance
- None 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