GENETISURE DX LABELING KIT, -20C PART

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.

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. FOLLOWING SECTIONS WERE CORRECTED: D2, H7 AND H11.

Description of Event or Problem

A COMPLAINT WAS RECEIVED FROM A JAPAN CUSTOMER THAT THEY HAD NOTICED A SHIFT IN THEIR FEMALE REFERENCE DNA AT CHROMOSOME 12 IN GENETISURE DX LABELLING KIT. 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 BENEFIT FROM THE SUBSEQUENT DIAGNOSIS FROM FOLLOWING 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

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. AGILENT HAS INITIATED THE RECALL PROCESS, AND A SUPPLEMENTAL REPORT WILL BE SUBMITTED ONCE THE ADDITIONAL INFORMATION IS RECEIVED.