iChemVELOCITY Automated Urine Chemistry Systems. An in vitro diagnostic medical device (IVD). 의 리콜

Recall

RC-2017-RN-00170-1

Class II

2017-02-03

Australia

DHTGA

https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00170-1

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. inadequate dosing may lead to incorrect patient results which may not be detected by quality control, or to a delay in reporting results. incorrect patient results might be observed as an unexpected discrepancy between instrument results and the patient's clinical picture. the greatest impact could occur when proteinuria is not detected. a control failure could indicate inadequate dosing caused by probe bending/misalignment that occurred due to probe mishandling during maintenance or troubleshooting, or through use of an incorrect tube type or placement on the system.

The manufacturer has designed a Pipette Mounting Block that will better secure the probe, avoiding misalignment and bending. A Beckman Coulter representative will contact customers to schedule a service visit for implementation. In the interim, the following actions are recommended: - Avoid bumping the probe during maintenance or troubleshooting. - Carefully follow instructions in your Operator’s Manual, PN 301-7146 or 300-4449, for utilising the Pipette Safety Parking Device, using the approved tube types, and removing tube caps before sample analysis to avoid probe-tube collisions. - Perform a patient cross check or run quality control after performing maintenance or troubleshooting in the probe area. If there are concerns with the results, contact Beckman Coulter. - Consult with the Laboratory Director to determine whether a retrospective review of results is clinically warranted.