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Sysmex America, Inc. recalls Sysmex PS-10 Sample Preparation System Catalog number:BQ716341 - Product Usage: is a fully automated, user configurable

Recalled July 29, 2020 · FDA recall Z-2687-2020 · Sysmex America

Hazard
Insufficient amount of antibody without an error message or alarm · FDA Class II
Units
8 units
Sold at
US Nationwide distribution including in the states of AL, AZ, MD, WA, FL, IL.

Description

Insufficient amount of antibody without an error message or alarm

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(s)
Sysmex America, Inc.

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov

Sysmex America, Inc. recalls Sysmex PS-10 Sample Preparation System Catalog number:BQ716341 - Product Usage: is a fully automated, user configurable | RecallWatchUSA