IP ROUTINE VI TAPED, BLUE

Additional Manufacturer Narrative

THE CUSTOMER REPORTED SEVERAL IP ROUTINES VI TAPED, BLUE, P/N 39LC-550-2-L, LOT 20250519-4 OPENED DURING PROCESSING. TRENDING ANALYSIS FROM 23 DEC 2024 TO 23 DEC 2025 REPORTED NO (0) OTHER RELATED OCCURRENCES OF THIS ISSUE FOR THIS PRODUCT LOT. A REVIEW OF THE PRODUCT HISTORY 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 TESTING WAS COMPLETED WITH FOUR (4) CASSETTES FROM THIS LOT. THE CASSETTES WERE RAN THROUGH THE PROCESSOR ON A 4 HOUR STANDARD FACTORY RUN ON THE PELORIS. AFTER PROCESSING NONE OF THE CASSETTES HAD OPENED. THE ROOT CAUSE COULD NOT BE UNEQUIVOCALLY DETERMINED FROM THE INFORMATION AVAILABLE. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

Description of Event or Problem

ON 22 DECEMBER 2025, A COMPLAINT WAS RAISED WITH THE FOLLOWING INFORMATION: "SEVERAL CASSETTES HAVE OPENED DURING THE PROCESSING, LOT # 20250519-4." ON 05 JANUARY 2026, THE LEICA CUSTOMER CARE SPECIALIST ADVISED THE LEICA ASSOCIATE, QUALITY ASSURANCE THAT THE AWARENESS DATE FOR THIS EVENT WAS 28 NOVEMBER 2025.