APTIMA COMBO 2 ASSAY

Description of Event or Problem

ON OCTOBER 10TH 2024, A CUSTOMER REPORTED THREE SUSPECTED FALSE POSITIVE GC RESULTS USING THE APTIMA COMBO 2 ASSAY. SAMPLES WERE TESTED IN WORKLIST: 002536-20240916-45 ((B)(6)) & 002536-20241003-12 (24M113251 & 24M113075), USING ASSAY LOTS 899831 AND 901175 ON PANTHER INSTRUMENT SERIAL NUMBER (B)(6) AND TESTED POSITIVE FOR GC. CUSTOMER NOTED THE RESULTS WERE QUESTIONED BY THE PHYSICIAN: TWO SAMPLES CAME FROM PREGNANT PATIENTS AND THE OTHER SAMPLE CAME FROM A PATIENT WHOSE SPOUSE TESTED NEGATIVE FOR GC. ONE OF THE PATIENTS (SAMPLE ID ((B)(6)) RECEIVED TREATMENT BASED ON THE POSITIVE GC RESULT AND NO ADDITIONAL TESTING WAS PERFORMED. NO NEGATIVE IMPACTS FROM THE TREATMENT WERE REPORTED. SAMPLES FROM THE OTHER TWO PATIENTS WERE RECOLLECTED RESULTED GC NEGATIVE. HOLOGIC HAS NOT BEEN INFORMED OF ANY ADVERSE PATIENT OUTCOMES RELATED TO THIS SITUATION.

Additional Manufacturer Narrative

HOLOGIC TECHNICAL SUPPORT (TS) REVIEWED THE LOGS PROVIDED BY THE CUSTOMER AND NOTED NO HARDWARE, SOFTWARE, OR KIT-RELATED ISSUES. TS NOTED THAT ALL THREE SAMPLES HAD TYPICAL KINETICS AND DID NOT FIND ANY INDICATION OF CONTAMINATION. TS NOTED THAT THE SAMPLES WERE EITHER MISHANDLED OR WERE TRUE LOW-TARGET SAMPLES. HOLOGIC PRODUCT APPLICATION SPECIALIST (PAS) PROVIDED A SECONDARY REVIEW AND CONFIRMED THERE WERE NO HARDWARE OR REAGENT PREPARATION ISSUES. PAS AGREED THAT THE SAMPLES WERE EITHER MISHANDLED OR WERE LOW-TARGET. HOLOGIC PERFORMED A RISK ASSESSMENT AND NOTED NO PRODUCT IMPACT. HOLOGIC HAS NOT BEEN INFORMED OF ANY ADVERSE PATIENT OUTCOMES RELATED TO THIS SITUATION.