FDAJuly 6, 2020device
Sysmex PS-10 Sample Preparation System Catalog number:BQ716341 - Product Usage: is a fully automated, user configurable, open system intended for use to prepare human specimens for subsequent analysis on flow cytometers.
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
Insufficient amount of antibody without an error message or alarm
What to do
FDA enforcement status: Terminated
Brands named
sysmex americasysmex
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
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- CPSCPetzl America Recalls SIMBA and SWAN EASYFIT Harnesses Due to Risk of Serious Injury or Death from Fall Hazard2026-05-14
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- FDADigitalDiagnost C90 Flex/Value/Chest/ER. Model Number: 712035.2026-05-01
- CPSCAcer America Corporation Recalls Two-Wheeled Folding Electric Due to Risk of Injury from Fall Hazard2026-04-30
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