UroVysion 02J27-011Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00884999002128), received between Jun 29, 2016 and Feb 24, 2020 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Defective Component” (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.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 24, 2020Device Damaged Prior to Use; Device Damaged Prior to Use

  CUSTOMER REPORTS RECEIPT OF BROKEN PROBECHEK UROVYSION CONTROL SLIDES. THERE WAS NO PATIENT INVOLVED AS THE WHOLESALER DISCOVERED IT ON (B)(6) 2020, AND CONTACTED HIS SALES REPRESENTATIVE. THERE WERE NO INJURIES ASSOCIATED WITH THIS OBSERVATION. THIS INCIDENT IS BEING REPORTED TO FDA BECAUSE THE INCIDENT OCCURRED IN (B)(6) USING PROBECHEK UROVYSION CONTROL SLIDES, LIST NUMBER 02J27-11, WHICH IS ALSO US FDA APPROVED.

  Patient problems: No Patient Involvement

  MAUDE report 9747843 ↗
• MalfunctionJun 29, 2016Defective Component; Defective Component

  THE PROBECHEK UROVYSION CONTROL SLIDES ARE NON-HYBRIDIZED SLIDES PREPARED WITH CULTURED NORMAL MALE LYMPHOBLAST CELLS AND CULTURED BLADDER CANCER CELL LINES. EACH CONTROL SLIDE CONSISTS OF TWO SEPARATE TARGET AREAS IN WHICH EACH OF THE DIFFERENT CELL TYPES HAVE BEEN APPLIED. THE CELL LINES ARE HARVESTED, FIXED IN SUSPENSION MEDIUM AND APPLIED TO THE GLASS MICROSCOPE SLIDES IN A METHOD OPTIMAL FOR FISH (FLUORESCENCE IN SITU HYBRIDIZATION). CUSTOMER REPORTED THAT THE TECHNICIAN OPENED A BOX OF UROVYSION CONTROL SLIDES AND DISCOVERED BROKEN SLIDES. THE CUSTOMER REPORTED THAT PERSONAL PROTECTIVE EQUIPMENT WAS UTILIZED AND THERE WERE NO INJURIES. THE PROBECHEK UROVYSION BLADDER KIT CONTROL SLIDES PACKAGE INSERT INDICATES THAT THESE SLIDES CONTAIN HUMAN SOURCED AND/OR POTENTIALLY INFECTIOUS COMPONENTS. IF THE ISSUE OF CUSTOMERS RECEIVING BROKEN PROBECHEK SLIDES WERE TO RECUR, IT IS POSSIBLE THAT CUSTOMERS COULD CUT THEMSELVES WITH A POTENTIALLY INFECTIOUS SLIDE. THEREFORE, RECURRENCE OF THIS ISSUE COULD POTENTIALLY CAUSE OR CONTRIBUTE TO SERIOUS INJURY OR DEATH.

  Patient problems: No Patient Involvement

  MAUDE report 5760643 ↗