Leica Biosystems recalls HistoCore PELORIS 3 rapid tissue processors with tubing leakage in the manifold. Affected models include specific serial numbers and software versions. No action is required but check your device.
There is a leakage issue associated with the tubing in the manifold of the instrument.
Leica Biosystems is recalling HistoCore PELORIS 3 rapid tissue processors due to a potential tubing leakage issue in the instrument's manifold. This could lead to improper tissue sample preparation if the leakage occurs during use. Affected units have specific serial numbers and software versions.
The tubing in the manifold of the instrument may leak, which could cause improper tissue sample preparation. However, the recall does not specify that this leakage leads to injury or damage to users, only that it affects the device's functionality.
Users of the HistoCore PELORIS 3 rapid tissue processor for laboratory tissue sample preparation are most at risk if they have the affected serial numbers or software versions listed in the recall. This includes medical and research facilities using the device.
Check if your HistoCore PELORIS 3 has the model/catalg number 45.0005/45.7512.501 A11 and software version 3.4.0. Affected units have specific serial numbers listed in the recall notice.
Verify your HistoCore PELORIS 3's model number, software version, and serial number against the list provided in the recall notice.
The recall does not require any action; users can continue using the device as normal if they have a different model or software version.
The recall lists specific serial numbers starting with 45111117 up to 45111152, with additional numbers added on August 12, 2025.
The recall states there is a leakage issue but does not mention any risk of injury or serious harm to users.
We’ve drafted a message you can send Leica Biosystems to request your refund or repair — edit it as you like.
Subject: Recall Z-1683-2025 — Leica Biosystems Leica Biosystems Hello, I own a Leica Biosystems that is covered by recall Z-1683-2025 from Leica Biosystems. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.