iChem Velocity Urine Chemistry Strips. An in vitro diagnostic medical device (IVD) 의 리콜

Recall

RC-2015-RN-00806-1

Class II

2015-09-04

Australia

DHTGA

https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00806-1

The manufacturer, iris international has determined that sample probe misalignment or bending on the ichemvelocity may lead to a remote possibility of false negative results due to inadequate strip dosing. the manufacturer'sinvestigation was initiated based on customer complaints for control failures. iris international has become aware of a manufacturing defect where a glucose pad was placed in the location intended for the protein pad on a subset of vials numbered 14996 through 15859 (with the exception of vials 15315 and 15316 within that series) within lot number 7204081a.The manufacturing defect will cause:· consistent false negative results in the presence of proteinuria.· false positive urine protein results may occur when patient specimen contains glucose.· quality control failures for protein results.

Beckman Coulter is advising users to inspect and discard any remaining inventory of affected vials. Beckman Coulter recommends consulting with the Laboratory Director to determine if a review of previously reported results is required. This action has been closed-out on 18/08/2016.