ACTIVFLO ROUTINE I-TAPED- WHITE 1000
Received Feb 5, 2025 · Event occurred Jan 9, 2025
Report 1419341-2025-00022 · MDR key 21315923
Device
Generic name
Cassettes, Tissue
Manufacturer
Leica BiosystemsModel number
ACTIVFLO ROUTINE I-TAPED- WHITE 1000Catalog number
39LC-500-1-L
Lot number
20241022
Product problems
- Separation Problem
- Separation Problem
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
DEVICE HISTORY REVIEW WAS COMPLETED. THERE WERE NO DEVIATIONS OR NON-CONFORMANCES ASSOCIATED WITH THIS LOT. TRENDING ANALYSIS REPORTED ONE (1) OTHER RELATED OCCURRENCE OF THIS ISSUE FOR THIS PRODUCT LOT. QUALITY CONTROL TESTING WAS COMPLETE AND PASSED. RETAIN SAMPLES WERE TESTED. THE ISSUE WAS NOT DUPLICATED AS THE PRODUCT WAS ALREADY TESTED FROM PRODUCT RELEASE. A CUSTOMER RETURNED WAS REQUESTED. IF ADDITIONAL INFORMATION IS RECEIVED AN ADDITIONAL FOLLOW UP MDR WILL BE SUBMITTED.
Description of Event or Problem
ON 09 JAN 2025 THE CUSTOMER REPORTED TWO (2) ACTIVFLO ROUTINE I-TAPED- WHITE 1000, P/N 39LC-500-1-L, LOT 20241022 OPENED IN THE PROCESSOR. THE CUSTOMER WAS ABLE TO FIND THE PATIENT TISSUE AND WERE ABLE TO DISTINGUISH BY TISSUE TYPE. THERE WAS NO RE-BIOPSY REQUIRED.