WHITE X-TRA SLIDES NON-CLIPPED (1440)
Received Jan 8, 2026 · Event occurred Dec 10, 2025
Report 1419341-2026-00001 · MDR key 24014595
Device
Generic name
Slides, Microscope
Manufacturer
Knittel GlaserModel number
WHITE X-TRA SLIDES NON-CLIPPED (1440)Catalog number
3800200AE
Lot number
4900072897
Product problems
- Adverse Event Without Identified Device or Use Problem
- Insufficient Device Problem Information
Patient
NA · Unknown
- Insufficient Information
Narrative
Additional Manufacturer Narrative
THE CUSTOMER REPORTED SEEING TISSUE FLOAT AWAY WHEN USING WHITE X-TRA SLIDES NON-CLIPPED (1440), P/N: 3800200AE, LOT: 4900072897. TRENDING ANALYSIS FROM 23 DEC 2024 TO 23 DEC 2025 REPORTED NO (0) OTHER RELATED OCCURRENCES OF THIS ISSUE FOR THIS PRODUCT LOT. AS MANUFACTURER INVESTIGATION OF THIS COMPLAINT BY LEICA BIOSYSTEMS IS IN PROGRESS, THE ROOT CAUSE OF THIS EVENT HAS NOT YET BEEN DETERMINED. IF ADDITIONAL INFORMATION IS RECEIVED A FOLLOW UP MDR WILL BE SUBMITTED.
Description of Event or Problem
ON (B)(6) 2025, THE CUSTOMER CONTACTED LEICA BIOSYSTEMS AND REPORTED "WITH CERTAIN ANTIBODIES: ON (B)(6), P16, CYCLIN, INHIBIN, ER, PR, C-ERB, BETA CATENIN, KI67, THE TISSUE FLOATS OFF THE LEICA X-TRA SLIDES." NO ADVERSE IMPACT TO A PATIENT HAS BEEN REPORTED TO THE MANUFACTURER TO DATE.
Additional Manufacturer Narrative
THE PRODUCT HISTORY WAS REVIEWED AND DID NOT IDENTIFY INFORMATION IN THE MANUFACTURING RECORD FOR THIS PRODUCT THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE PROBLEM REPORTED IN THIS COMPLAINT. RETURN FOR LOT 4900072897 WAS TESTED FOR TISSUE ADHESION. THREE DIFFERENT TISSUE TYPES (TONSIL, SKIN, AND LIVER) WERE CUT AND MOUNTED ON THE SLIDES. ALL SLIDES WERE RUN THROUGH AN H&E ON THE STAINER. UPON H&E COMPLETION, NO SLIDES SHOWED ANY ISSUES WITH TISSUE ADHESION. THE ROOT CAUSE COULD NOT BE UNEQUIVOCALLY DETERMINED FROM THE INFORMATION AVAILABLE. IF ADDITIONAL INFORMATION IS RECEIVED A FOLLOW UP REPORT WILL BE SUBMITTED.