Reported Sep 30, 2015 · Terminated

The Leica ASP6025 Tissue Processor. Pathology and Hematology Departments. The Leica ASP6025 Tissue Processor is an…

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?

  • The Leica ASP6025 Tissue Processor. Pathology and Hematology Departments. The Leica ASP6025 Tissue Processor is an automated system used to process tissue specimens for examination through fixation, dehydration and infiltration.
Lot codes and dates
  • Product CodeLeica
  • ASP6025 Serial Numbers
    • 163
    • 169
    • 200-729
    • 731
    • 733
    • 735
    • 737
    • 739
    • 741
    • 743
    • 745
    • 747
    • 749
    • 751
    • 753
    • 755
    • 757
    • 759
    • 761
    • 763
    • 765
    • 767
    • 769
    • 771
    • 773
    • 775
    • 777
    • 779
    • 781
    • 783
    • 785
    • 787
    • 789
    • 791
    • 793
    • 795
    • 797
    • 799
    • 801
    • 803
    • 805
    • 807
    • 809
    • 811
Amount recalled
U.S. Quantity Distributed: 163 systems; Foreign Quantity Diistributed: 410 systems.

Where it was sold

Why it was recalled

The ASP6025 Tissue Processor instrument is incorrectly getting into a state of bottle empty during retort filling, after passing the fill lever sensor 2 and prior to reaching level sensor 3, thus not completing a 5 litre fill.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Jan 5, 2017 · Data as of Sep 19, 5:21 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.