HistoCore PELORIS 3 recall
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…
Why was HistoCore PELORIS 3 recalled?
There is a leakage issue associated with the tubing in the manifold of the instrument.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
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.
- 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…
- Recalling firm
- Leica Biosystems Melbourne Pty Ltd
- Quantity
- 77 units
- Distribution
- US States: AZ, CA, FL, MN, NJ, NY, NC, OH, PA, TN, TX, UT, VA, and WI.
- Recall date
- May 7, 2025
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)