Recall Z-1815-2013— Leica Microsystems, Inc.

Class II FDA medical device recall by Leica Microsystems, Inc., initiated 2012-11-13, terminated 2017-01-05. FDA's recall record names no specific 510(k) clearance for this event. Product: Leica ASP6025 Vacuum Tissue Processor The Leica ASP6025 is a modular tissue processor for the following laboratory applications: fixation, dehydration, infiltration with intermedium, and the paraffin infiltration of histological tissue specimens.. Reason: The Instruction for Use 1v9 Ref F and all previous versions specify incorrect dimensions for the Ready To Use (RTU) bottles from other suppliers than Leica. In case of a pressure failure of the device in combination with a bottle with incorrect dimensions, overflow can cause contamination of reagents. Additionally, the current instructions for use does not highlight the importance to check the filling levels of all reagent bottles (RTU and system bottles) prior to every process run. Without this important information, risk of tissue damage or loss is possible. Therefore the missing information will be distributed to all customers by a Field Service Notice..

Recalling firm

Leica Microsystems, Inc.

Classification

Class II

Status

Terminated

Initiated

2012-11-13

Terminated

2017-01-05

Firm location

Buffalo Grove, IL, United States

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