Sysmex America, Inc.: Medical Device Recall in 2020 - (Recall #: Z-2687-2020)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2020.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: July 6, 2020

Date Posted: July 29, 2020

Recall Number: Z-2687-2020

Event ID: 85959

Reason for Recall:

Insufficient amount of antibody without an error message or alarm

Status: Terminated

Product Quantity: 8 units

Code Information:

Serial Numbers: 1906007896 1907014703 1908002274 1908002273 1907014704 1903011967 1903011968 1903011966

Distribution Pattern:

US Nationwide distribution including in the states of AL, AZ, MD, WA, FL, IL.

Voluntary or Mandated:

Voluntary: Firm initiated