Beckman Coulter Inc. recalls Coulter PrepPlus 2, Part Number 378600, Product Usage: The COULTER PrepPlus 2, when used in combination with the COULTE…

Recall date

May 22, 2017

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2690-2017

FDA classification

Class II

Brand / firm

Beckman Coulter Inc.

Sold / distributed

Worldwide Distribution

Why it was recalled

When samples are prepared using the PrepPlus or PrepPlus 2 sample preparation systems and then run on a Flow cytometer, there is an imprecision in the absolute counts on only the first tube in a run.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Coulter PrepPlus 2, Part Number 378600, Product Usage: The COULTER PrepPlus 2, when used in combination with the COULTER TQPrep Workstation, is intended to prepare human whole blood for In Vitro Diagnostic (IVD) Use with cleared Beckman Coulter IVD applications on cleared Beckman Coulter flow cytometers (FC500, Navios and Navios EX). The COULTER PrepPlus 2 is a microprocessor-controlled pipetting and diluting system, designed for automating sample preparation or assay methods. It is capable of aspirating and dispensing liquid samples.