Recall Z-2689-2017 ยท PER Automated Pipetting, Diluting And Specimen Processing Workstations For Flow Cytometric Analysis
Beckman Coulter Inc.
Coulter PrepPlus, Part Number 286600, Product Usage: The COULTER PrepPlus 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.
| 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 | 43 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 |