Sysmex America, Inc.: Device Recall
Recall #Z-1113-2025 · 01/06/2025
Class II: Risk
Recall Details
- Recall Number
- Z-1113-2025
- Classification
- Class II
- Product Type
- Device
- Recalling Firm
- Sysmex America, Inc.
- Status
- Ongoing
- Date Initiated
- 01/06/2025
- Location
- Lincolnshire, IL, United States
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 32 units
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.
Product Description
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 cytometric analysis.
Distribution Pattern
US Nationwide.
Other Recalls by Sysmex America, Inc.
- Class II: Risk 12/15/2025
Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.