Leica Biosystems 38440502Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 20849832022101), received between Dec 22, 2025 and Dec 22, 2025 — classified as 1 malfunction.

The most frequently reported specific device problem is “Break” (1 report).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 22, 2025Break; Break

  ON 03 DECEMBER 2025, LEICA BIOSYSTEMS WAS MADE AWARE OF AN INCIDENT REPORTED TO HEALTH CANADA BY THE CUSTOMER. THE CUSTOMER PROVIDED THE FOLLOWING DETAILS: "AT EMBEDDING OF OUTPATIENT¿S TISSUE SPECIMEN IN HISTOLOGY DEPARTMENT, THERE SHOULD HAVE BEEN TWO PIECES OF TISSUE IN THE CASSETTE, BUT CASSETTE WAS FOUND EMPTY. INTERNAL TAB ON CASSETTE WAS OBSERVED TO BE BROKEN. GROSSING BASKET WAS EMPTY. ONE PIECE WAS FOUND IN THE PROCESSOR RETORT; THE SECOND PIECE WAS LOST. THE FOUND PIECE OF TISSUE WAS EMBEDDED IN BLOCK X AND THREE LEVELS WERE CUT AND STAINED WITH HEMATOXYLIN AND EOSIN; PATHOLOGIST REVIEWED AND CONFIRMED IT WAS THE CORRECT TISSUE TYPE. SLIDE WAS LABELED AS PART C. BLOCK X WAS MELTED AND TISSUE RE-EMBEDDED IN PART C CASSETTE. (TISSUE SPECIMEN WAS SUFFICIENT FOR PATHOLOGICAL ANALYSIS; NO SUBSEQUENT PROCEDURE WAS REQUIRED TO PROCURE A SECOND TISSUE SPECIMEN.)" ON 03 DECEMBER 2025, THE FOLLOWING INFORMATION WAS DOCUMENTED: "TISSUE SPECIMEN WAS SUFFICIENT FOR PATHOLOGICAL ANALYSIS; NO SUBSEQUENT PROCEDURE WAS REQUIRED TO PROCURE A SECOND TISSUE SPECIMEN."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23873393 ↗