Cobas e 801 Analytical Unit. An in vitro diagnostic medical device. 의 리콜

Recall

RC-2018-RN-00215-1

Class II

2018-04-04

Australia

DHTGA

https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2018-RN-00215-1

Roche has identified an issue with the syringe plunger on the cobas e 801 analytical unit prewash (pw) syringe assembly. this issue may also occur on the instrument’s r1 or r2 reagent syringe assembly. investigations by the manufacturer have determined that depending on the affected syringe, r1, r2 or prewash liquids may not be pipetted correctly.In the worst case scenario during the cobas e 801 analytical unit initialisation steps, the plunger may crack leading to an impaired syringe function. this may affect the pipetting as follows:- if the prewash syringe plunger is broken, the cobas e 801 module cannot detect it and no alarm is issued. in this instance, the prewash step required by most assays will not be performed and an impact on measurement results cannot be excluded.- if the r1 or r2 syringe plunger is broken, a system alarm "345-1 warning abnormal low signal" is generated and data alarm (.

Roche Diagnostics has contacted affected sites and arranged for the installation of a hardware modification kit which ensures correct positioning and movement of the syringe plungers to prevent the issue from occurring.