cobas 8000 modular analyser series. An in vitro diagnostic medical device (IVD) 의 리콜

Recall

RC-2017-RN-00381-1

Class II

2017-03-27

Australia

DHTGA

https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00381-1

Roche have identified incorrect information regarding acceptable non-standard tube (nst) diameter in the operator’s manual for the cobas 8000 modular analyser series. version 5.0 of the operator’s manual for this system (published 1 july 2016) incorrectly states that 11 to 16 mm diameter nsts may be used on the cobas e 602 module and cobas e 801 module. this was found in the chapter “specifications of containers”, section “list of non-standard tubes”.This typographical error has now been corrected in version 5.1 of the manual (published 6 february 2017), to state that only 13 to 16 mm diameter nsts may be used on the cobas e 602 module or cobas e 801 module. version 4.2.1 and all prior versions of the operator’s manual also state the correct acceptable nst diameters. to date, no customer complaints regarding this issue have been received.

Roche is advising users to ensure that only tubes with a diameter of 13 to 16mm are used on the cobas e 602 and cobas e 801 modules. Users are requested to replace any available Version 5.0 cobas 8000 operator’s manual in your laboratory network with Version 5.1, which contains the correct non-standard tube diameter information. This updated version is also available for download.