Leica Biosystems 39LC-550-2-LRecalls & reported problems
Leica Biosystems Richmond, Inc. · IP Routine VI Cassettes, Taped, Blue · Class 1
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 20849832018180), received between Jan 21, 2026 and Jan 21, 2026 — classified as 1 malfunction.
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 Problem1
Patient problems
- Insufficient Information1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 21, 2026Adverse Event Without Identified Device or Use Problem
ON 22 DECEMBER 2025, A COMPLAINT WAS RAISED WITH THE FOLLOWING INFORMATION: "SEVERAL CASSETTES HAVE OPENED DURING THE PROCESSING, LOT # 20250519-4." ON 05 JANUARY 2026, THE LEICA CUSTOMER CARE SPECIALIST ADVISED THE LEICA ASSOCIATE, QUALITY ASSURANCE THAT THE AWARENESS DATE FOR THIS EVENT WAS 28 NOVEMBER 2025.
Patient problems: Insufficient Information
MAUDE report 24139608 ↗
Other CASSETTES, TISSUE devices
- Leica Biosystems 38440501Leica Biosystems Richmond, Inc. · CASSETTES, TISSUE3 reports
- Leica Biosystems 39LC-500-9-LLeica Biosystems Richmond, Inc. · CASSETTES, TISSUE2 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-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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