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Type of Product Medical Device
TGA Recall Reference RC-2018-RN-00417-1
Product Name/Description Accu-Chek Inform II Test. An in vitro diagnostic medical device (IVD)

Material Number: 05942861022

Lot: Number: 476639

ARTG Number: 286479
(Roche Diagnostics Australia - Clinical chemistry substrate IVDs)
Recall Action Level Hospital
Recall Action Classification Class II
Recall Action Commencement Date 7/05/2018
Responsible Entity Roche Diagnostics Australia Pty Limited
Reason/Issue Roche has identified a certain test strip lot that potentially shows an increase in strip errors prior to dosing. Due to the designed fail-safe in the blood glucose meter, the issue can be identified by the error message displayed on the meter upon strip insertion or through the device not recognising the test strip, respectively.
However, in a limited number of cases the test strip can produce a biased result i.e. a false high or low value, which might not be detected easily and which could lead to erroneous therapy adaptations.
Recall Action Recall
Recall Action Instructions Roche is advising customers to identify affected lot numbers from inventory. If impacted stock is identified users should discontinue using strips immediately and discard. Users should use an alternate unaffected lot to monitor patients' glucose levels.

This action has been closed out on the 16/10/2018.
Contact Information 1800 645 619 - Roche Customer Care