Recall Z-2690-2017 ยท PER Automated Pipetting, Diluting And Specimen Processing Workstations For Flow Cytometric Analysis
Beckman Coulter Inc.
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 pipet
| Date | May 22, 2017 |
| Status | Terminated |
| Reason | 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. |
| Root cause | Software design |
| Action | The recalling firm initiated their recall by letter disseminated via email on 05/22/2017. The letter requested the following actions be taken: 1. Insert an empty daughter tube in place of a patient sample as the first tube in the carousel that is programmed for the addition of Flow-Count Fluorospheres. 2. Refer to the COULTER PrepPlus Operators Guide / PrepPlus 2 Instructions for Use (IFU) for instructions on adding Flow-Count Fluorospheres to daughter tubes. 3. Review all results following the flow cytometer data review instructions referenced in the associated IFU. Beckman Coul |
| Quantity | 473 units |
| Distribution | Worldwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K130253 | TQ-PREP WORKSTATION, PREPPLUS 2 WORKSTATION Beckman Coulter, Inc., Jul 15, 2013 |