| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2017-RN-00381-1 |
| Product Name/Description |
cobas 8000 modular analyser series. An in vitro diagnostic medical device (IVD)
cobas e 602 module
Material Number: 05990378001
cobas e 801 module
Material Number: 07682913001
ARTG Number: 173887 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
27/03/2017 |
| Responsible Entity |
|
| Reason/Issue |
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. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
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.
This action has been closed-out on 22/03/2018. |
| Contact Information |
02 9860 2357 - Roche Diagnostics Australia |