Skip to content

HistoCore PELORIS 3, Model/Catalog Number:… recallZ-1683-2025 · Leica Biosystems Melbourne Pty Ltd · initiated Apr 2, 2025

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Leica Biosystems Melbourne Pty Ltd or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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

FDA root cause category: Release of Material/Component prior to receiving test results

What the company is doing

An URGENT MEDICAL DEVICE RECALL notification letter dated 3/31/25 was sent to customers. ACTIONS REQUIRED 1. If leakage from the instrument is observed in the drip tray or surrounding the instrument, please follow your laboratory's leakage containment/safety protocol. If a protocol is running, wait for the run to finish, switch off the instrument and contact your local Leica Biosystems representative immediately. 2. If no leakage has been observed from the instrument, continue using it as normal. Conduct routine monitoring for leakage until the on-site inspection is completed. 3. Your local Leica Biosystems representative will contact you to schedule an onsite inspection of your instruments tubing and reseat the tubes if needed. 4. Confirm Receipt of Recall Notice Please confirm receipt of this notice by signing and dating the attached Recall Acknowledgement Form by email to the following email address: lbsme/[email protected] Please contact your local Leica Biosystems representative immediately if you have any questions or concerns. An URGENT MEDICAL DEVICE RECALL notification letter dated 8/13/25 was sent to customers. ACTIONS REQUIRED 1. If leakage from the instrument is observed in the drip tray or surrounding the instrument, please follow your laboratory's leakage containment/safety protocol. If a protocol is running, wait for the run to finish, switch off the instrument and contact your local Leica Biosystems representative immediately. 2. If no leakage has been observed from the instrument, continue using it as normal. Conduct routine monitoring for leakage until the on-site inspection is completed. 3. Your local Leica Biosystems representative will contact you to schedule an onsite inspection of your instrument(s) for replacing the tubing and/or density meter manifold if needed. 4. Confirm Receipt of Recall Notice Please confirm receipt of this notice by signing and dating the attached Recall Acknowledgement Form by email to the following email ad

Recall details

Recall number
Z-1683-2025
Status
Open, Classified
Initiated by the company
Apr 2, 2025
Posted by the FDA
Apr 28, 2025
Recalling firm
Leica Biosystems Melbourne Pty Ltd
Quantity
77 units
Product code
IEO
Distribution
US States: AZ, CA, FL, MN, NJ, NY, NC, OH, PA, TN, TX, UT, VA, and WI.

Product description

HistoCore PELORIS 3, Model/Catalog Number: 45.0005/45.7512.501 A11, Software Version: 3.4.0. The HistoCore PELORIS 3 Rapid Tissue Processor is a dual retort rapid tissue processor used to prepare tissue samples.

Code information (models, lots, serial numbers)

Show the full code information (1k characters)

UDI-DI: 09349458004811; 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 UPDATE: Additional Serial Numbers: 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, 45111136, 45111137, 45111139, 45111140, 45111141, 45111142, 45111143, 45111144, 45111145, 45111146, 45111147, 45111148, 45111149, 45111150, 45111151, 45111152, 45111163.

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Sources and updates

How recalls are matched to devices · Editorial policy · Report an error on this page