WHITE X-TRA SLIDES CASE, 1440, MADE IN USA
Received Mar 25, 2026 · Event occurred Feb 27, 2026
Report 1419341-2026-00005 · MDR key 24694804
Device
Generic name
Slides, Microscope
Manufacturer
Leica Biosystems Richmond Inc.Model number
WHITE X-TRA SLIDES CASE, 1440, MADE IN USACatalog number
3800200
Lot number
073025-2
Product problems
- Adverse Event Without Identified Device or Use Problem
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THE CUSTOMER REPORTED THE TISSUE DID NOT STICK TO WHITE X-TRA SLIDES CASE, 1440, MADE IN USA, P/N 3800200, LOT 073025-2. NO ADVERSE EVENTS WERE REPORTED. TRENDING ANALYSIS FROM (B)(6) 2025 TO (B)(6) 2026 REPORTED NO (0) OTHER RELATED OCCURRENCES OF THIS ISSUE FOR THIS PRODUCT LOT. 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. RETAIN SAMPLES FOR LOT 073025-2 WERE 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.
Description of Event or Problem
ON (B)(6) 2026, THE CUSTOMER CONTACTED LEICA BIOSYSTEMS AND REPORTED "TISSUE WILL NOT STICK TO SLIDES. THESE ARE THE NON-AE SLIDES." ON (B)(6) 2026, THE LEICA SENIOR SALES CONSULTANT ADVISED NO PATIENT TISSUE SAMPLES WERE LOST AS A RESULT OF THIS EVENT.