Leica Biosystems 39LC-500-9-LRecalls & reported problems
Leica Biosystems Richmond, Inc. · IP ActivFlo Routine I, Taped, Yellow · Class 1
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 20849832022446), received between Jun 25, 2025 and Jul 22, 2025 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem2
- Insufficient Device Problem Information1
Patient problems
- Insufficient Information1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 22, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
ON 23 JUNE 2025, LEICA BIOSYSTEMS RECEIVED THE FOLLOWING INFORMATION: "YELLOW CASSETTES AREN¿T STAYING CLOSED. THEY KEEP POPPING OPEN ON THEM. ABOUT 15% OF THE CASSETTES ARE HAVING ISSUES." NO ADVERSE CONSEQUENCE(S) TO A PATIENT(S) HAS BEEN REPORTED TO THE MANUFACTURER TO DATE.
Patient problems: Insufficient Information
MAUDE report 22572837 ↗MalfunctionJun 25, 2025Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information
ON 31 MAY 2025, LEICA BIOSYSTEMS RECEIVED THE FOLLOWING INFORMATION: "THE PA'S HAVE BEEN HAVING ISSUES WITH THE YELLOW CASSETTES "POPPING" BACK OPEN. SEEMS LIKE THE SMALL PLASTIC LOCKING PIECES ON THE FRONT OF THE CASSETTE ARE WEAKER THAN USUAL AND HAVE BEEN BREAKING OR NOT STRONG ENOUGH TO LOCK PROPERLY." ON (B)(6) 2025, THE CUSTOMER ADVISED "THERE WAS NO LOSS OF TISSUE. THE ISSUE WAS NOTICED AT GROSSING. THE LIDS WOULD KEEP POPPING BACK OPEN, SO THEY¿D PRINT NEW CASSETTES UNTIL THEY GOT SOME THAT STAYED CLOSE. IT ONLY WAS AN ISSUE AT GROSSING. NO RE BIOPSY NEEDED. IT WAS ALL TYPES OF OUR RUSH CASES: BREAST, LUNG, KIDNEY, COLON ETC." NO ADVERSE CONSEQUENCE(S) TO A PATIENT(S) HAS BEEN REPORTED TO THE MANUFACTURER TO DATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22333395 ↗
Other CASSETTES, TISSUE devices
- Leica Biosystems 38440501Leica Biosystems Richmond, Inc. · CASSETTES, TISSUE3 reports
- Tissue-Tek® Paraform® 7019Sakura Finetek U.S.A., Inc. · CASSETTES, TISSUE1 report
- Tissue-Tek® Paraform® 7020Sakura Finetek U.S.A., Inc. · CASSETTES, TISSUE1 report
- Leica Biosystems 38440502Leica Biosystems Richmond, Inc. · CASSETTES, TISSUE1 report
- Leica Biosystems 39LC-550-2-LLeica Biosystems Richmond, Inc. · CASSETTES, TISSUE1 report
- Leica Biosystems 39LC-500-2-LLeica Biosystems Richmond, Inc. · CASSETTES, TISSUE1 report
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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