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Type of Product	Medical Device
TGA Recall Reference	RC-2016-RN-00563-1
Product Name/Description	Novocastra Liquid Mouse Monoclonal Antibody Calretinin. An in vitro diagnostic medical device (IVD) Product Code: 1ml NCL-L-CALRET-566 Lot Numbers: 6025204, 6029060, 6036060 Only to be used in combination with: Diluent Lot Numbers AR9352 SLBL4196V, SLBL8154V, SLBM1997V, SLBM3199V AR9352-CN SLBL8154V SLBM1997V RE7133-CE 6035000 RE7133-CN 6035115 ARTG Number: 178442
Recall Action Level	Hospital
Recall Action Classification	Class II
Recall Action Commencement Date	29/04/2016
Responsible Entity	Leica Microsystems Pty Ltd
Reason/Issue	In the event that the product is used with diluents other than those listed, it may not provide adequate staining. When used according to the Instructions for Use with appropriate positive controls, the failure to adequately stain would be apparent to the user on the control tissue and on the patient tissue. In these instances, the absence of adequate staining of tissue is likely to result in a delay in obtaining the results of IHC / ISH staining and, in a worst-case scenario, could cause a delay in the diagnosis or classification of a neoplasm.
Recall Action	Recall for Product Correction
Recall Action Instructions	Leica is advising users to only use Novocastra Liquid Mouse Monoclonal Antibody Calretinin with the specified diluents. There is no need for retrospective review of tissue staining if appropriate positive controls were properly used and interpreted during the immuno / in situ staining. This action has been closed-out on 25/01/2017.
Contact Information	03 9211 7535 - Leica Biosystems