Drug recall
Sysmex PS-10 Sample Preparation System with software version 1.5 and 1.6., Catalog Number BQ716341. Product…
FDA recall event 96107 · Class II · Sysmex America, Inc.
Key facts
| Event ID | 96107 |
|---|---|
| Recall numbers | Z-1113-2025 |
| Recalling firm | Sysmex America, Inc. |
| Product type | Devices |
| Products | Sysmex PS-10 Sample Preparation System with software version 1.5 and 1.6., Catalog Number BQ716341. Product usage for automated pipetting, diluting, and specimen processing workstations for flow… |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Sysmex was made aware of a report of false results due to carry-over caused by the sporadic omission of the probe wash step during antibody pipetting on the PS-10 Sample Preparation System. |
| Initiation date | Jan 6, 2025 |
| Report date | Feb 12, 2025 |
| 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: