PERMAFLEX PLUS ADHESIVE SLIDES, WHITE

Description of Event or Problem

ON 09 APRIL 2025, LEICA BIOSYSTEMS RECEIVED THE FOLLOWING INFORMATION: "TISSUE FALLING OFF MY IHC SLIDES THAT GO ON THE BOND WITHIN THE LAST FEW DAYS/WEEKS. NOTHING HAS CHANGED. LEICA PERMAFLEX PLUS SLIDES THAT I RECENTLY RECEIVED. THIS IS THE MOST RECENT LOT." AS AT 08 MAY 2025, LEICA BIOSYSTEMS HAS NOT RECEIVED INFORMATION AS TO EITHER THE FINAL STATUS OF THE PATIENT SLIDES INVOLVED IN THIS EVENT OR THE PATIENT IMPACT/OUTCOME. NO ADVERSE CONSEQUENCE(S) TO A PATIENT(S) HAS BEEN REPORTED TO THE MANUFACTURER TO DATE.

Additional Manufacturer Narrative

MANUFACTURER TESTING OF RETAIN SAMPLES WAS UNABLE TO REPLICATE THE "TISSUE FALLING OFF MY IHC SLIDES..." REPORTED BY THE CUSTOMER. THE ROOT CAUSE FOR THE "TISSUE FALLING OFF MY IHC SLIDES..." REPORTED BY THE CUSTOMER COULD NOT BE UNEQUIVOCALLY DETERMINED FROM THE INFORMATION AVAILABLE. NO ADVERSE CONSEQUENCE(S) TO A PATIENT(S) HAS BEEN REPORTED TO THE MANUFACTURER TO DATE. IF ADDITIONAL INFORMATION IS RECEIVED AN ADDITIONAL FOLLOW UP MDR WILL BE SUBMITTED.