VENTANA HE 600 Transfer Fluid 06544380001Recalls & reported problems
Ventana Medical Systems, Inc. · 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 04015630974788), received between Apr 22, 2025 and Apr 22, 2025 — classified as 1 malfunction.
The most frequently reported specific device problem is “Missing 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
- Missing Information1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 22, 2025Missing Information; Missing Information
THE INITIAL REPORTER COMPLAINED OF AN ISSUE WITH A SHIPMENT OF VENTANA HE 600 TRANSFER FLUID, AS ONE OF THE BOTTLES HAD NO INFORMATION ON THE LABEL. THE ISSUE WAS DETECTED INTERNALLY IN A LOCAL ROCHE WAREHOUSE, AND THE AFFECTED PRODUCT WAS SET UNDER QUARANTINE. THE LABEL WAS COMPLETELY WHITE EXCEPT FOR THE TITLE. THE EXPIRATION DATE, LOT NUMBER, AND NAME OF THE MANUFACTURER WERE ALL MISSING. THE OTHER BOTTLES HAD THE LOT NUMBER M25095. ONLY ONE BOTTLE OUT OF 200 BOTTLES WAS MISSING THE INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21881912 ↗
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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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