Z-2690-2017 Class II Terminated
FDA device recall Z-2690-2017 was initiated by Beckman Coulter Inc. on May 22, 2017 and is designated Class II. 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. The recall status is terminated (terminated March 31, 2021). Affected quantity: 473 units.
Recall Details
- Product Type
- Devices
- Report Date
- July 12, 2017
- Initiation Date
- May 22, 2017
- Termination Date
- March 31, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 473 units
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.
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.
Distribution Pattern
Worldwide Distribution
Code Information
All serial numbers currently in the field