Sysmex PS-10 Sample Preparation System Recalled for Insufficient Antibody
Sysmex America, Inc. is recalling eight PS-10 Sample Preparation Systems because they may contain insufficient antibody without triggering an error message or alarm.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a risk-of-harm product (medical device) where injury has not yet been reported, fitting the High severity criteria.
Plain-English summary
Sysmex America, Inc. is recalling eight units of the Sysmex PS-10 Sample Preparation System (Catalog number BQ716341). The device is a fully automated, user-configurable, open system intended to prepare human specimens for subsequent analysis on flow cytometers.
The recall is being issued because the systems may contain an insufficient amount of antibody without providing an error message or alarm to the user. This defect could potentially affect the accuracy of specimen preparation.
The affected units were distributed nationwide in the United States, including in the states of Alabama, Arizona, Maryland, Washington, Florida, and Illinois. The specific serial numbers for the recalled units are 1906007896, 1907014703, 1908002274, 1908002273, 1907014704, 1903011967, 1903011968, and 1903011966. Users should check their serial numbers and contact Sysmex America, Inc. for further instructions.
The recalled product
- Product
- 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.
- Manufacturer
- Sysmex America, Inc.
- Affected units
- 8
Distribution
Related recalls
Same manufacturer · Sysmex America, Inc.
See all →- ModerateLaboratory tube sorters recalled over a lift that may drop unexpectedly
FDA (Devices) · 2026-01-28
- HighSysmex PS-10 Sample Preparation System Recalled for False Test Results
FDA (Devices) · 2025-02-12
- SevereSysmex CV-11 Sample Unit Recalled for Combustion Hazard
FDA (Devices) · 2020-04-22
- HighSysmex CF-70 Blood Smear Transporter Recalled for Software Mismatch Hazard
FDA (Devices) · 2020-04-22
- ModerateSysmex Fluorocell PLT Reagent Recalled for Inaccurate Platelet Counts
FDA (Devices) · 2018-09-05
Same hazard · inaccurate results
See all →- HighHealthmark Protein Test Recalled Due to Expired Ingredient
FDA (Devices) · 2026-09-02
- HighHardyDisk AST Cefiderocol 30µg for In Vitro Testing Recalled Due to Incorrect Cartridges
FDA (Devices) · 2026-08-12
- HighGEM Premier 7000 with iQM3 Blood Analysis Systems Recalled for Solution Concentration Issues
FDA (Devices) · 2026-08-12
- Highepoc BGEM BUN Test Card for epoc Blood Analysis System
FDA (Devices) · 2026-05-06
- HighAbbott i-STAT EG7+ Blood Gas Cartridges Reporting Inaccurate Results
FDA (Devices) · 2026-05-06