Beckman Coulter Inc.: Medical Device Recall in 2017 - (Recall #: Z-2690-2017)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2017.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: May 22, 2017

Date Posted: July 12, 2017

Recall Number: Z-2690-2017

Event ID: 77362

Reason for Recall:

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.

Status: Terminated

Product Quantity: 473 units

Code Information:

All serial numbers currently in the field

Distribution Pattern:

Worldwide Distribution

Voluntary or Mandated:

Voluntary: Firm initiated