Drug recall
Sysmex XN-Series Fluorocell PLT, Catalog #CD994563. Distributed in the U.S.A. by Sysmex America, Inc…
FDA recall event 80716 · Class II · Sysmex America, Inc.
Key facts
| Event ID | 80716 |
|---|---|
| Recall numbers | Z-2953-2018 |
| Recalling firm | Sysmex America, Inc. |
| Product type | Devices |
| Products | 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… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | The fluorescent platelet counts (PLT-F) and immature platelet fraction (IPF) values can be falsely low when using affected lots of Fluorocell PLT. |
| Initiation date | Jul 27, 2018 |
| Report date | Sep 5, 2018 |
| Termination date | Jul 8, 2019 |
| City | Lincolnshire |
| State | IL |
| Country | United States |
| FEI number | 3009711478 |
At a glance
- 1–9 Products in this recall
- 1–9 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: