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Type of Product	Medical Device
TGA Recall Reference	RC-2015-RN-00717-1
Product Name/Description	Leica ASP200S & Leica ASP300S. In vitro diagnostic medical device (IVD) (Histology sample processing instruments) Leica ASP200S Product Code: 14048043625 Serial Numbers: 5329, 5448, 5528, 5707 Leica ASP300S Product Code: 14047643514 Serial Numbers: 5361, 5639, 5721, 5872, 6057 ARTG Number: 189287
Recall Action Level	Hospital
Recall Action Classification	Class II
Recall Action Commencement Date	5/08/2015
Responsible Entity	Leica Microsystems Pty Ltd
Reason/Issue	Leica Microsystems recently became aware that affected devices have an incorrect internal wiring to the remote alarm plug, which can cause the remote alarm to not function correctly in the case of an instrument failure. The missing alarm signal could lead to suboptimal quality tissue processing. In some cases, a re-biopsy of the patient could be necessary in order to obtain another viable tissue sample.
Recall Action	Recall for Product Correction
Recall Action Instructions	A Leica Service Engineer will correct the internal wiring and check the remote alarm functionality. This action has been closed out on the 17/10/2018.
Contact Information	03 9211 7535 - Leica Biosystems