WHITE X-TRA SLIDES NON-CLIPPED (1440)

Description of Event or Problem

ON (B)(6) 2026, THE CUSTOMER CONTACTED LEICA BIOSYSTEMS AND REPORTED "SLIDES ARE NOT CHARGED. THEY ARE SAYING RISK OF TISSUE LOSS. SOME CHARGED SOME UNCHARGED."

Additional Manufacturer Narrative

THE CUSTOMER REPORTED WHITE X-TRA SLIDES NON-CLIPPED (1440), P/N 3800200AE, LOT 4900078019 HAD NO CHARGE THAT COULD CAUSE TISSUE LOSS. NO ADVERSE EVENTS WERE REPORTED. TRENDING ANALYSIS FROM 19 MAR 2025 TO 19 MAR 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. ADDITIONAL INFORMATION HAS BEEN REQUESTED FROM THE CUSTOMER TO ASSIST WITH THE COMPLETION OF THE INVESTIGATION. 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.

Additional Manufacturer Narrative

TESTING OF SLIDES FROM THE SAME PRODUCT LOT RETAINED BY THE MANUFACTURER COULD NOT REPLICATE THE "SLIDES ARE NOT CHARGED. THEY ARE SAYING RISK OF TISSUE LOSS. SOME CHARGED SOME UNCHARGED" REPORTED BY THE CUSTOMER. THE ROOT CAUSE FOR THE "SLIDES ARE NOT CHARGED. THEY ARE SAYING RISK OF TISSUE LOSS. SOME CHARGED SOME UNCHARGED" REPORTED BY THE CUSTOMER COULD NOT BE DETERMINED BY THE MANUFACTURER. IF ADDITIONAL INFORMATION IS RECEIVED A FOLLOW UP MDR WILL BE SUBMITTED.