Z-1683-2025Class II

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

Name: Z-1683-2025 HistoCore PELORIS 3, Model/Catalog Number: 45.0005/45.7512.501 A11, Software Version: 3.4.0. The HistoCore...
Creator: Leica Biosystems Melbourne Pty Ltd
Published: 2025-04-02
License: https://open.fda.gov/license/

Leica Biosystems Melbourne Pty Ltd / initiated 2025-04-02 / Open, Classified

FDA source

Leica Biosystems Melbourne Pty Ltd began a recall of 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... on 2025-04-02. FDA classified it as Class II and gives the reason as "There is a leakage issue associated with the tubing in the manifold of the instrument". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-1683-2025
Classification: Class II
Status: Open, Classified
Initiated: 2025-04-02
Posted: 2025-04-28
Recalling firm: Leica Biosystems Melbourne Pty Ltd
Product: 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.
Product code: IEO Processor, Tissue, Automated
Reason for recall: There is a leakage issue associated with the tubing in the manifold of the instrument.
FDA root cause: Release of Material/Component prior to receiving test results
Action: 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
Quantity in commerce: 77 units
Distribution: US States: AZ, CA, FL, MN, NJ, NY, NC, OH, PA, TN, TX, UT, VA, and WI.
Product codes and lots: 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.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1683-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1683-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-05-07	2025-04-28

Product code IEO

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)