Vysis 06N38-010Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00884999025738), received between Aug 10, 2016 and Feb 26, 2018 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Device Damaged Prior to Use” (2 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 26, 2018Device Damaged Prior to Use; Device Damaged Prior to Use

  THE PROBECHEK ALK POSITIVE CONTROL SLIDES ARE INTENDED FOR USE AS AN ASSAY CONTROL FOR APPROPRIATE HYBRIDIZATION CONDITIONS DURING ROUTINE USE OF THE VYSIS ALK BREAK APART FISH PROBE KIT (LIST NO. 06N38). THE PROBECHEK ALK POSITIVE CONTROL SLIDES SHOULD BE ASSAYED IN CONJUNCTION WITH THE USER'S SPECIMEN SLIDES ACCORDING TO THE PACKAGE INSERT FOR THE VYSIS ALK BREAK APART FISH PROBE KIT (LIST NO. 06N38). CUSTOMER REPORTED THAT WHEN OPENING ALK POSITIVE CONTROL SLIDES ONE SLIDE WAS BROKEN. THE CUSTOMER DID NOT REPORT ANY INJURY. LAB TECHNICIAN WAS WEARING PROTECTIVE EQUIPMENT. THE OUTER BOX APPEARED TO BE SLIGHTLY RECESSED LIKE PRESSURE HAD BEEN PUT ON IT. THE PROBECHEK ALK POSITIVE CONTROL SLIDE PACKAGE INSERT INDICATES THESE SLIDES CONTAIN HUMAN SOURCED AND/OR INFECTIOUS COMPONENTS. IF THIS EVENT WERE TO RECUR, IT IS POSSIBLE CUSTOMERS COULD CUT THEMSELVES WITH A POTENTIALLY INFECTIOUS SLIDE. THERE IS NO PATIENT INVOLVED AS THE BROKEN SLIDE WAS OBSERVED DURING OPENING OF THE PRODUCT BY A LABORATORY TECHNICIAN.

  Patient problems: No Patient Involvement

  MAUDE report 7298180 ↗
• MalfunctionAug 10, 2016Device Damaged Prior to Use; Device Damaged Prior to Use

  THE PROBECHEK ALK POSITIVE CONTROL SLIDES ARE INTENDED FOR USE AS AN ASSAY CONTROL FOR APPROPRIATE HYBRIDIZATION CONDITIONS DURING ROUTINE USE OF THE VYSIS ALK BREAK APART FISH PROBE KIT (LIST NO. 06N38). THE PROBECHEK ALK POSITIVE CONTROL SLIDES SHOULD BE ASSAYED IN CONJUNCTION WITH THE USER'S SPECIMEN SLIDES ACCORDING TO THE PACKAGE INSERT FOR THE VYSIS ALK BREAK FISH PROBE KIT. A CUSTOMER REPORTED THAT 2 OUT OF 5 PROBECHEK ALK POSITIVE CONTROL SLIDES WERE RECEIVED BROKEN. THERE WAS NO REPORT OF INJURY. THE PROBECHECK ALK POSITIVE CONTROL SLIDE PACKAGE INSERT INDICATES THESE SLIDES CONTAIN HUMAN SOURCED AND/OR POTENTIALLY INFECTIOUS COMPONENTS. IF THIS EVENT WERE TO RECUR, IT IS POSSIBLE CUSTOMERS COULD CUT THEMSELVES WITH A POTENTIALLY INFECTIOUS SLIDE.

  Patient problems: No Patient Involvement

  MAUDE report 5864091 ↗