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
451111174511115445111155451111564511115745111158451111594511116045111161451111624511116445111166451111674511116845111169451111704511117145111174451111754511117645111177451111784511117945111180451111814511118245111183. 08/12/2025
- UPDATEAdditional
- Serial Numbers
77 of 77 codes
451110644511106545111067451110684511106945111070451110714511107345111074451110754511107645111077451110784511107945111080451110814511108245111084451110864511108745111088451110894511109045111091451110924511109345111094451110954511109745111098451110994511110045111101451111024511110345111104451111084511110945111110451111114511111245111113451111144511111545111116451111204511112245111123451111244511112545111126451111274511112845111129451111304511113145111132451111334511113445111135
- 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.
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