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Type of Product Medical Device
TGA Recall Reference RC-2012-RN-00790-3
Product Name/Description Cobas 4800 BRAF V600 Mutation Test (acquired genetic alteration IVD). An in vitro diagnostic medical device (IVD)

Material Number: 05985595190

Lot Number: R03607

ARTG Number: 192394
Recall Action Level Hospital
Recall Action Classification Class III
Recall Action Commencement Date 6/08/2012
Responsible Entity Roche Diagnostics Australia Pty Limited
Reason/Issue The test kit was assembled containing two components, the WT Control and the MU Control, that were released for non-commercial internal use only.
Recall Action Recall
Recall Action Instructions Discontinue the use of affected product and dispose them appropriately. There is no requirement to re-test samples tested with the affected product. Roche will be supplying replacement stock when available.
Contact Information 02 9860 2329 - Roche Diagnostics Australia