Device recall
Z-2953-2018: Sysmex XN-Series Fluorocell PLT, Catalog #CD994563. Distributed in the U.S.A. by…
FDA device recall · Class II · Sysmex America, Inc.
Key facts
| Recall number (Z-number) | Z-2953-2018 |
|---|---|
| Recall event | 80716 |
| Product | Sysmex XN-Series Fluorocell PLT, Catalog #CD994563. Distributed in the U.S.A. by Sysmex America, Inc., Lincolnshire, IL. 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 | Jul 8, 2019 |
| 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