Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Leica ASP6025 Vacuum Tissue Processor The Leica ASP6025 is a Recalled by Leica Microsystems, Inc. Due to The Instruction for Use 1v9 Ref F and...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Leica Microsystems, Inc. directly.
Affected Products
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.
Quantity: 128 machines
Why Was This Recalled?
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.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Leica Microsystems, Inc.
Leica Microsystems, Inc. has 40 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report