Drug recall
Sysmex Fluorocell(R) PLT Fluorocell PLT is used to stain platelets in a diluted blood sample for the counting…
FDA recall event 78134 · Class II · Sysmex America, Inc.
Key facts
| Event ID | 78134 |
|---|---|
| Recall numbers | Z-0045-2018 |
| Recalling firm | Sysmex America, Inc. |
| Product type | Devices |
| Products | Sysmex Fluorocell(R) PLT 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 |
| Classification | Class II |
| Status | Completed |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | There is potential that fluorescent platelet (PLT-F) and immature platelet fraction (IPF%, #) results obtained using the lots listed above may exhibit lower than actual PLT-F and IPF values. The issue… |
| Initiation date | Sep 8, 2017 |
| Report date | Nov 1, 2017 |
| 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: