GENETISURE DX LABELING KIT, -20C PART

Additional Manufacturer Narrative

WHILE THERE WAS NO DIRECT PATIENT HARM REPORTED FOR THIS EVENT; IT IS BEING REPORTED DUE TO POTENTIAL FOR HARM AS THE FALSE NEGATIVE RESULTS RAISE THE CLINICAL CONCERN OF MISSING A CLINICALLY RELEVANT CHROMOSOMAL TESTING.

Description of Event or Problem

AGILENT WAS MADE AWARE OF A JAPAN CUSTOMER THAT NOTED THE LOG RATIO ON CHROMOSOME 12 WAS UNUSUALLY SHIFTED. THIS WAS CLARIFIED AS A REPEATABLE PHENOMENON WITH THE FEMALE REFERENCE DNA THAT WAS ABSENT WHEN THE SAME SAMPLE WAS PAIRED WITH MALE REFERENCE DNA. FURTHER INVESTIGATION BY AGILENT R&D AND QUALITY INDICATES THAT K1201-64105 GENETISURE DX LABELING KIT -20C (LOT 0006798023) WAS PACKAGED WITH PRODUCT THAT WAS BLOCKED AND SHOULD NOT HAVE BEEN ABLE TO BE PACKAGED (PN 5190-7317 HUMAN REFERENCE DNA FEMALE ALIQUOT 25 UG (LOT 0006793917)). THIS D1 BULK MATERIAL IS AFFECTED BY THE MOSAIC ABERRATION. THIS PRODUCT WAS BLOCKED AS IT MAY RESULT IN A BASELINE SHIFT ON FEMALE DNA SAMPLE ON CHROMOSOME 12, THAT MAY GENERATE FALSE POSITIVE OR FALSE NEGATIVE RESULT. SINCE THIS PRODUCT IS NOT INTENDED TO BE USED AS STANDALONE OR DIAGNOSTIC PURPOSES, WHILE FALSE POSITIVE RESULT CAN BE IDENTIFIED AND CORRECTED WITH FURTHER TESTS, FEMALE REFERENCE DNA MOSAIC ABERRATION MAY LEAD TO FALSE NEGATIVE RESULT, WHICH WOULD NOT BENEFIT FROM SUBSEQUENT TESTS. THEREFORE, THIS EVENT IS BEING REPORTED AS THE FALSE NEGATIVE RESULTS RAISE THE CLINICAL CONCERN OF MISSING A CLINICALLY RELEVANT CHROMOSOMAL TESTING. NO DIRECT PATIENT IMPACT WAS INDICATED AT THIS TIME.

Additional Manufacturer Narrative

AGILENT TECHNOLOGIES HAS INITIATED THE RECALL PROCESS UNDER RECALL EVENT ID 96484 IN MARCH 2025, NOTIFYING ALL CUSTOMERS THAT HAVE THE AFFECTED PRODUCT IN THEIR INVENTORY TO IMMEDIATELY DISCARD THE PRODUCT AND A REPLACEMENT WILL BE PROVIDED. CAPA01657 HAS ADDRESSED THE ISSUE, AND AGILENT TECHNOLOGIES HAS DETERMINED THAT THE ROOT CAUSE OF THIS ISSUE WAS PROCESS EXECUTION FAILURES AND HUMAN ERROR IN ENFORCING MATERIAL CONTAINMENT PROCEDURES. AGILENT TECHNOLOGIES IS ACTIVELY WORKING TO UPDATE AND ALIGN PROCEDURES TO ENSURE THAT THE MANUFACTURING ALERT AND STOP SHIPMENT PROCESSES EXPLICITLY DEFINE MATERIAL CONTAINMENT STEPS AND REFERENCES. THIS INCLUDES CONDUCT TRAINING FOR PERSONNEL INVOLVED IN MATERIAL CONTROL TO REINFORCE THE MANUFACTURING ALERT PROCESS AND THE PROPER EXECUTION OF MATERIAL CONTAINMENT, AS WELL AS IMPROVING PROCEDURAL OVERSIGHT TO ENSURE COMPLIANCE WITH CONTAINMENT MEASURES AND PREVENT RECURRENCE. THIS ACTION PLAN WILL LEAD TO MORE ROBUST PROCESSES, BETTER-TRAINED PERSONNEL, AND A HIGHER LEVEL OF COMPLIANCE. THE FOLLOWING SECTIONS WERE UPDATED: B4, G3, G6, H2, H6, H7, H9, H11.