Leica Biosystems Melbourne Pty Ltd recalls HistoCore PELORIS 3, Model/Catalog Number: 45.0005/45.7512.5

Hazard / Issue

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

Issued by

FDA

Affected States: AZ, CA, FL, MN, NJ, NY, NC, OH, PA, TN, TX, UT, VA, WI

Lot/Code Info: 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.