Leica TP1020 VF/accessories 1491020US02Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 04049188003102), received between Jul 24, 2025 and Jul 24, 2025 — classified as 4 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (4 reports).

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.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryJul 24, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  ON (B)(6) 2025, LEICA BIOSYSTEMS (LBS) RECEIVED A DEVICE MALFUNCTION COMPLAINT WHERE LABORATORY STAFF MEMBERS WERE EXPOSED TO REAGENT FUMES. THE COMPLAINANT INFORMED LBS THAT SEVERAL STAFF MEMBERS REPORTED DIZZINESS, VOMITING, NAUSEA, HEADACHES AND MORE AND SEVERAL WENT TO URGENT CARE FOR FURTHER EVALUATION AND TESTING. THE LBS FIELD APPLICATIONS SPECIALIST (FAS) INVESTIGATING THIS EVENT WITH THE COMPLAINANT DOCUMENTED THE FOLLOWING, "CUSTOMER MENTIONED THE INCIDENT WHICH EVERYONE FELT SICK WAS DURING THE FIRST WEEK OF MAY AND WHEN ASKED TO CONFIRM THE DATE, SHE MENTIONED SHE THINKS IT WAS MAY 4TH AND BASED THE DATE OFF TIMESTAMPS OF EMAILS AND TEXT MESSAGES SURROUNDING THE INCIDENT." ON (B)(6) 2025, THE LBS FAS DOCUMENTED THE FOLLOWING INFORMATION FROM THE COMPLAINANT, "...3 STAFF MEMBERS DECIDED AMONG THEMSELVES TO SEEK MEDICAL TREATMENT. 2 OF THE 3 STAFF MEMBERS WERE FOUND TO HAVE A PRESENCE OF OVER-EXPOSURE BASED ON TESTING." THE TYPE OF TESTING IS UNKNOWN. THE COMPLAINANT ALSO MENTIONED, "...ONE OF THE STAFF MEMBERS WAS RECOMMEND GLUTATHIONE INJECTION, IVS, HYPERBARIC OXYGEN." WHEN THE CUSTOMER WAS ASKED ABOUT THE TYPE OF TREATMENT, THE CUSTOMER DID NOT DISCLOSE ANY DETAILS AS

  Patient problems: Dizziness; Headache; Nausea; Vomiting

  MAUDE report 22602469 ↗
• InjuryJul 24, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  ON 25 JUNE 2025, A DEVICE MALFUNCTION INCIDENT WAS REPORTED TO LEICA BIOSYSTEMS (LBS) TECHNICAL SUPPORT. ON 26 JUNE 2025, LEICA BIOSYSTEMS (LBS) RECEIVED INFORMATION THAT PATIENT SPECIMENS WERE UNREADABLE. THE LBS FIELD APPLICATIONS SPECIALIST (FAS) INVESTIGATING THIS EVENT WITH THE COMPLAINANT DOCUMENTED THE FOLLOWING, "THE SPECIMENS PROCESSING DURING THIS DEVICE MALFUNCTION OCCURRED SOMETIME DURING THE LATTER STEPS OF THE PROTOCOL. THE BLOCKS AND SLIDES OF THE SPECIMENS FROM THIS RUN WERE SENT TO THEIR OF SITE LAB FOR READING. IT WAS DISCOVERED THAT SOME SPECIMENS WERE UNREADABLE..." ON 30 JUNE 2025, THE LBS FAS CONFIRMED WITH THE COMPLAINANT THAT, "...IT WAS ACTUALLY 3 PATIENTS RE-BIOPSIED RELATING TO THE INCIDENT THAT AFFECTED THE SPECIMENS FROM THE DATE OF (B)(6) 2025." ON 10 JULY 2025, THE LBS FAS PROVIDED FURTHER CONFIRMATION THAT, "WHEN ASKED IF THE AFFECTED SAMPLES WERE RELATED TO THE DEVICE MALFUNCTION, THE CUSTOMER COULD NOT CONFIRM. THE CUSTOMER REPORTED THE DEVICE MALFUNCTION OCCURRED APRIL 27TH 2025 AND WERE MADE AWARE OF UNREADABLE CASES ON MAY 16TH. THE CUSTOMER ESTIMATED THAT THE PROCESSING RUN CONTAINING THE AFFECTED THE CASES MAY HAVE BEEN PROCESSED JUST DAYS PRI

  Patient problems: Insufficient Information

  MAUDE report 22602130 ↗
• InjuryJul 24, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  ON 25 JUNE 2025, A DEVICE MALFUNCTION INCIDENT WAS REPORTED TO LEICA BIOSYSTEMS (LBS) TECHNICAL SUPPORT. ON 26 JUNE 2025, LEICA BIOSYSTEMS (LBS) RECEIVED INFORMATION THAT PATIENT SPECIMENS WERE UNREADABLE. THE LBS FIELD APPLICATIONS SPECIALIST (FAS) INVESTIGATING THIS EVENT WITH THE COMPLAINANT DOCUMENTED THE FOLLOWING, ¿THE SPECIMENS PROCESSING DURING THIS DEVICE MALFUNCTION OCCURRED SOMETIME DURING THE LATTER STEPS OF THE PROTOCOL. THE BLOCKS AND SLIDES OF THE SPECIMENS FROM THIS RUN WERE SENT TO THEM OF SITE LAB FOR READING. IT WAS DISCOVERED THAT SOME SPECIMENS WERE UNREADABLE¿¿ ON 30 JUNE 2025, THE LBS FAS CONFIRMED WITH THE COMPLAINANT THAT, ¿¿IT WAS ACTUALLY 3 PATIENTS RE-BIOPSIED RELATING TO THE INCIDENT THAT AFFECTED THE SPECIMENS FROM THE DATE OF (B)(6) 2025.¿ ON 10 JULY 2025, THE LBS FAS PROVIDED FURTHER CONFIRMATION THAT, ¿WHEN ASKED IF THE AFFECTED SAMPLES WERE RELATED TO THE DEVICE MALFUNCTION, THE CUSTOMER COULD NOT CONFIRM. THE CUSTOMER REPORTED THE DEVICE MALFUNCTION OCCURRED (B)(6) 2025 AND WERE MADE AWARE OF UNREADABLE CASES ON (B)(6). THE CUSTOMER ESTIMATED THAT THE PROCESSING RUN CONTAINING THE AFFECTED CASES MAY HAVE BEEN PROCESSED JUST DAYS PRIOR TO RECEIVING

  Patient problems: Insufficient Information

  MAUDE report 22586154 ↗
• InjuryJul 24, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  ON 25 JUNE 2025, LEICA BIOSYSTEMS (LBS) RECEIVED A DEVICE MALFUNCTION COMPLAINT WHERE LABORATORY STAFF MEMBERS WERE EXPOSED TO REAGENT FUMES. THE COMPLAINANT INFORMED LBS THAT SEVERAL STAFF MEMBERS REPORTED DIZZINESS, VOMITING, NAUSEA, HEADACHES AND MORE AND SEVERAL WENT TO URGENT CARE FOR FURTHER EVALUATION AND TESTING. THE LBS FIELD APPLICATIONS SPECIALIST (FAS) INVESTIGATING THIS EVENT WITH THE COMPLAINANT DOCUMENTED THE FOLLOWING, ¿CUSTOMER MENTIONED THE INCIDENT WHICH EVERYONE FELT SICK WAS DURING THE FIRST WEEK OF MAY AND WHEN ASKED TO CONFIRM THE DATE, SHE MENTIONED SHE THINKS IT WAS MAY 4TH AND BASED THE DATE OFF TIMESTAMPS OF EMAILS AND TEXT MESSAGES SURROUNDING THE INCIDENT.¿ ON 27 JUNE 2025, THE LBS FAS DOCUMENTED THE FOLLOWING INFORMATION FROM THE COMPLAINANT, ¿¿3 STAFF MEMBERS DECIDED AMONG THEMSELVES TO SEEK MEDICAL TREATMENT. 2 OF THE 3 STAFF MEMBERS WERE FOUND TO HAVE A PRESENCE OF OVER-EXPOSURE BASED ON TESTING.¿ THE TYPE OF TESTING IS UNKNOWN. THE COMPLAINANT ALSO MENTIONED, ¿¿ONE OF THE STAFF MEMBERS WAS RECOMMEND GLUTATHIONE INJECTION, IVS, HYPERBARIC OXYGEN.¿ WHEN THE CUSTOMER WAS ASKED ABOUT THE TYPE OF TREATMENT, THE CUSTOMER DID NOT DISCLOSE ANY DETAILS ASID

  Patient problems: Headache

  MAUDE report 22586152 ↗