Reported May 7, 2025 · Ongoing

HistoCore PELORIS 3, Model/Catalog Number: 45.0005/45.7512.501 A11, Software Version: 3.4.0. The HistoCore PELORIS 3…

Leica Biosystems Melbourne Pty Ltd.

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 Biosystems Melbourne Pty Ltd · 495 Blackburn Road · Mount Waverley · N/A

Is this the product you have?

  • HistoCore PELORIS 3
  • Model/Catalog Number45.0005/45.7512.501 A11
  • Software Version3.4.0. The HistoCore PELORIS 3 Rapid Tissue Processor is a dual retort rapid tissue processor used to prepare tissue samples
Lot codes and dates
  • UDI-DI09349458004811
  • Serial Numbers
    • 45111117
    • 45111154
    • 45111155
    • 45111156
    • 45111157
    • 45111158
    • 45111159
    • 45111160
    • 45111161
    • 45111162
    • 45111164
    • 45111166
    • 45111167
    • 45111168
    • 45111169
    • 45111170
    • 45111171
    • 45111174
    • 45111175
    • 45111176
    • 45111177
    • 45111178
    • 45111179
    • 45111180
    • 45111181
    • 45111182
    • 45111183. 08/12/2025
  • UPDATEAdditional
  • Serial Numbers

    77 of 77 codes

    • 45111064
    • 45111065
    • 45111067
    • 45111068
    • 45111069
    • 45111070
    • 45111071
    • 45111073
    • 45111074
    • 45111075
    • 45111076
    • 45111077
    • 45111078
    • 45111079
    • 45111080
    • 45111081
    • 45111082
    • 45111084
    • 45111086
    • 45111087
    • 45111088
    • 45111089
    • 45111090
    • 45111091
    • 45111092
    • 45111093
    • 45111094
    • 45111095
    • 45111097
    • 45111098
    • 45111099
    • 45111100
    • 45111101
    • 45111102
    • 45111103
    • 45111104
    • 45111108
    • 45111109
    • 45111110
    • 45111111
    • 45111112
    • 45111113
    • 45111114
    • 45111115
    • 45111116
    • 45111120
    • 45111122
    • 45111123
    • 45111124
    • 45111125
    • 45111126
    • 45111127
    • 45111128
    • 45111129
    • 45111130
    • 45111131
    • 45111132
    • 45111133
    • 45111134
    • 45111135
Amount recalled
77 units

Where it was sold

Why it was recalled

There is a leakage issue associated with the tubing in the manifold of the instrument.

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

Want the full recall guide?

The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

Free recall alerts

Get alerted about new Leica Biosystems Melbourne Pty Ltd. recalls

One email when a matching recall is published. No account, no cost, unsubscribe in one click.

Where this came from

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

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 7:33 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.