PrepPlus & PrepPlus 2. An in vitro diagnostic medical device (IVD) 의 리콜

Recall

RC-2017-RN-00717-1

Class II

2017-06-01

Australia

DHTGA

https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00717-1

As a result of internal investigations, beckman coulter has confirmed that 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. there is a software issue where an incorrect volume (aspiration/dispense) of flow-count reagent (used to determine lymphocyte population) is dispensed in the first tube position of the prepplus/prepplus 2 carousel. the issue may generate erroneous results for the reported parameters assayed on the sample in the first tube of the flow count worklist. any sample prepared on the prepplus/prepplus 2 in the first position of the carousel is subject to potential erroneous absolute count results for the reported parameters assayed on the sample in that tube. the potential magnitude of the error is a positive bias of up to 9.7% on the prepplus and 13.4% on the prepplus 2.

Beckman Coulter will be correcting the issue in the following PrepPlus 2 software release. In the interim, users are requested to 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 (refer to the Coulter PrepPlus Operators Guide or PrepPlus 2 Instructions for Use (IFU) for instructions on adding Flow-Count Fluorospheres to daughter tubes). In addition, users are advised to review all previously generated results with their Medical Director.