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Type of Product Medical Device
TGA Recall Reference RC-2015-RN-00229-1
Product Name/Description Cobas c 501 / c 502 and COBAS INTEGRA. An in vitro diagnostic medical device (IVD)

Material Number: 05 385 415 190
Affected lots: 69781101
Expiry Date: 30 Apr 2015

Subsequent lots: 60717101
Expiry Date: 31 Jan 2016
Recall Action Level Hospital
Recall Action Classification Class II
Recall Action Commencement Date 17/03/2015
Responsible Entity Roche Diagnostics Australia Pty Limited
Reason/Issue Following customer complaints regarding a 20% decrease in control levels when using third party controls (e.g. ThermoFisher LiqImmune) Roche has identified that reagent lot 697811 shows a negative bias of up to 54% compared to lot 604303.This negative bias could, in the worst case, lead to inaccurately low Homocysteine results.

This issue only occurs with EDTA plasma samples.
Recall Action Recall
Recall Action Instructions Roche is requesting their customers to discard any remaining units from the affected lot. This action has been closed-out on 18/08/2016.
Contact Information 1800 645 619 - Roche Diagnostics National Support Centre