FDA-Device2020-07-29Class II
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.
Sysmex America, Inc.
Hazard
Insufficient amount of antibody without an error message or alarm
Sold states
US Nationwide distribution including in the states of AL, AZ, MD, WA, FL, IL.
Affected count
8 units
Manufactured in
577 Aptakisic Rd, N/A, Lincolnshire, IL, United States
Products
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 notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2687-2020Don't want to check this manually?
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