Database updated: 27 October 2026

Safety Information

Medsafe Online Recall Database

Detail of Recall

Type of Product:Device
Medsafe Reference:21165
Brand Name:Roche Cobas modular 8000 annalyser system with cobas e602 module
Model:
Affected:version 5.0 cobas 8000 Operators Manual
Software version:
Recalling Organisation:Roche Diagnostics (NZ) Ltd
15 Rakino Way
Mt Wellington
AUCKLAND 1644
Contact Information:0800 363 622
Manufacturer:Roche Diagnostics GmbH
Issue:The cobas 8000 version 5.0 Operator's Manual, chapter 17 Specifications, section list of nonstandard tubes incorrectly states that 11 to 16 mm diameter non-standard tubes may be used on the cobas e602 module. Be aware that only 13 to 16 mm diameter non-standard tubes may be used on the cobas e602 module.
Recall action type:Correction
Recall action:Instructions for use to be updated
Level of recall:Hospital/Pharmacy/Laboratory
Date Commenced:1/3/2017
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