APTIMA COMBO 2 ASSAY

Additional Manufacturer Narrative

A CUSTOMER PROVIDED FEEDBACK ON THE TIGHTNESS OF THE CAPS OF THE HOLOGIC AC2 READY-MADE-REAGENT (RMR) BOTTLES. TECHNICIANS OPEN APPROXIMATELY 6-14 KITS A DAY AND AFTER THE 6TH KIT, IT HURTS THEIR HANDS. CUSTOMER CLAIMED THEY COULD NOT OPEN THE BOTTLES AND WILL ORDER BOTTLE OPENERS FOR THEIR LAB. HOLOGIC INQUIRED INTO THE CUSTOMER¿S REPORT OF PAIN TO SEE IF ANY TECHNICIAN HAD TO SEEK TREATMENT. CUSTOMER RELAYED THAT ONE TECHNICIAN REPORTED WRIST STRAIN ON (B)(6) 2024, AND RETURNED TO FULL WORK ACTIVITY IN (B)(6) 2024. AS OF (B)(6) 2024, THIS TECHNICIAN WAS STILL UNDERGOING MEDICAL CHECKS EVERY TWO WEEKS. HOLOGIC PERFORMED A RISK ASSESSMENT. THERE HAS BEEN ONE PRIOR INSTANCE OF A CUSTOMER REPORTING MEDICAL TREATMENT ALLEGEDLY NEEDED BECAUSE OF UNCAPPING RMR PRODUCT. HOLOGIC EXAMINED RETENTION MATERIALS AND FOUND THE REAGENTS TO FALL WITHIN THE MANUFACTURING SPECIFICATION FOR TORQUE VALUES.

Description of Event or Problem

ON OCTOBER 9, 2024, CUSTOMER RELAYED TO HOLOGIC THAT TECHNICIANS HAD HURT THEIR HANDS, ALLEGEDLY BY UNCAPPING OF HOLOGIC AC2 READY-MADE-REAGENT (RMR) BOTTLES. UPON FURTHER INQUIRY, HOLOGIC BECAME AWARE THAT A TECHNICIAN HAD REPORTED WRIST STRAIN ON (B)(6) 2024, AND WAS NOT ABLE TO RETURN TO FULL WORK ACTIVITY UNTIL (B)(6) 2024. AS OF (B)(6)2024, THE TECHNICIAN WAS STILL GOING THROUGH MEDICAL CHECKS EVERY TWO WEEKS.