Reported Aug 7, 2013 · Terminated
Leica ASP6025 Vacuum Tissue Processor The Leica ASP6025 is a modular tissue processor for the following laboratory…
Leica Microsystems, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Leica Microsystems, Inc. · 1700 Leider Ln · Buffalo Grove, IL · 60089-6622
Is this the product you have?
- Leica ASP6025 Vacuum Tissue Processor The Leica ASP6025 is a modular tissue processor for
- the following laboratory applicationsfixation, dehydration, infiltration with intermedium, and the paraffin infiltration of histological tissue specimens
- Lot codes and dates
- 1) Model ASP6025 120V/50-60 Hz
- Serial Numbers
1712002022042062082102122142162182202222242262282302322342362382402422442462482502522542562582602622642662682702722742762782802822842862882902922942) Model ASP6025 230V/50-60 Hz
- Serial Numbers
79 of 79 codes
162163168169170183184201203205207209211213215217219221223225227229231233235237239241243245247249251253255257259261263265267269271273275277279281283285287289291293295297299301303305
- Amount recalled
- 128 machines
Where it was sold
- Nationwide
Why it was 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.
This product could cause temporary or reversible health problems — stop using it.
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