Recall database

Automated Pipetting, Diluting And Specimen Processing Workstations For Flow Cytometric Analysis recalls

Drawn from openFDA device enforcement reports. Filter by severity, status, state, year, or manufacturer.

Showing 1–3 of 3 recalls

Class IIOngoingZ-1235-2026

Beckman Coulter, Inc. recalls CellMek SPS Sample Preparation System

Sample preparation system designed to automate staining, lysing, cell washing has a software error that causes samples to be dispensed close to or touching tube bottoms, which could dislodge fluid line, result in sample…

Beckman Coulter, Inc.FLFeb 11, 2026

Class IIOngoingZ-0412-2026

Beckman Coulter, Inc. recalls CellMek SPS Sample Preparation System

Automated pipetting, diluting and specimen processing workstations for flow cytometric analysis device instructions for use list incorrect dead volumes: Cassette Type/List volume/correct volume, B/750/1582 microliters, a…

Beckman Coulter, Inc.FLNov 5, 2025

Class IIOngoingZ-1113-2025

Sysmex America, Inc. recalls Sysmex PS-10 Sample Preparation System with software version 1.5 and 1.6.

Sysmex was made aware of a report of false results due to carry-over caused by the sporadic omission of the probe wash step during antibody pipetting on the PS-10 Sample Preparation System.

Sysmex America, Inc.ILFeb 12, 2025