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Type of Product	Medical Device
TGA Recall Reference	RC-2024-RN-00554-1
Product Name/Description	VENTANA anti-CD10 (SP67) Rabbit Monoclonal Primary Antibody. An in vitro diagnostic medical device (IVD). Systems: BenchMark GX, BenchMark XT/LT, BenchMark ULTRA, BenchMark ULTRA PLUS Material Number: 05857856001 Lot Numbers: J04613, J11853, J17541, J25047, J30286, K00982, K06239, K09880, K14266, K19784, K26461, and M00669 only ARTG 175635 Roche Diagnostics Australia Pty Limited - Immunohistology cell marker IVDs)
Recall Action Level	Hospital
Recall Action Classification	Class II
Recall Action Commencement Date	5/07/2024
Responsible Entity	Roche Diagnostics Australia Pty Limited
Reason/Issue	Risk of false positive results with specific lots of VENTANA anti-CD10 (SP67) Rabbit Monoclonal Primary Antibody due to high background of the above VENTANA anti-CD10 (SP67) Rabbit Monoclonal Primary Antibody (Material Number 05857856001).
Recall Action	Recall
Recall Action Instructions	· Please immediately discontinue the use of and discard any inventory of all affected lots. · Laboratories must review all positive results generated with the affected lots and follow their standard operating procedures to investigate any suspected false positive results generated with the affected lots. · If there are any erroneous results, please notify Roche Diagnostics Australia immediately. · Laboratories should continue to use the recommended Method Sheet protocol. In case the laboratory validated protocol that does not follow the Method Sheet recommendations, it is recommended to revalidate the protocol. · New VENTANA anti-CD10 (SP67) Rabbit Monoclonal Primary Antibody, is now available. Once the customer acknowledgement form has been returned, Roche will contact customers for reimbursement or replacement of stock.
Contact Information	1800 645 619 - Janet Thomson