Recall Z-1683-2025
Leica Biosystems Melbourne Pty Ltd · initiated April 2, 2025
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
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.
Codes / 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.
Reason for recall
There is a leakage issue associated with the tubing in the manifold of the instrument.
FDA-determined cause: Release of Material/Component prior to receiving test results
Action taken
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
Details
- Recall number
- Z-1683-2025
- Initiated
- April 2, 2025
- Posted by FDA
- April 28, 2025
- Product code
- IEO – Processor, Tissue, Automated
- Quantity
- 77 units
- Distribution
- US States: AZ, CA, FL, MN, NJ, NY, NC, OH, PA, TN, TX, UT, VA, and WI.
- Recalling firm
- Leica Biosystems Melbourne Pty Ltd, Mount Waverley