FDA recall Z-2687-2020

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.

Reason for recall

Insufficient amount of antibody without an error message or alarm

Distribution

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

Key facts

Status

Terminated

Initiation date

2020-07-06

Report date

2020-07-29

Termination date

2021-05-21

Voluntary/Mandated

Voluntary: Firm initiated

Location

Lincolnshire, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2687-2020