HistoCore PELORIS 3 (Leica Biosystems) – Tubing Leakage Issue (2025)
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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.
Brand
Leica Biosystems Melbourne Pty Ltd
Lot Codes / Batch Numbers
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.
Products Sold
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.
Leica Biosystems Melbourne Pty Ltd is recalling HistoCore PELORIS 3, Model/Catalog Number: 45.0005/45.7512.501 A11, Software Version: 3.4.0. The His due to There is a leakage issue associated with the tubing in the manifold of the instrument.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
There is a leakage issue associated with the tubing in the manifold of the instrument.
Recommended Action
Per FDA guidance
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/.rfa@leicabiosystems.com 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
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
AZ, CA, FL, MN, NJ, NY, NC, OH, PA, TN, TX, UT, VA, WI
Page updated: Jan 10, 2026