APTIMA COMBO 2 ASSAY

Additional Manufacturer Narrative

ON BEHALF OF THE CUSTOMER, A HOLOGIC MOLECULAR APPLICATIONS SPECIALIST REPORTED THE CUSTOMER¿S ISSUE TO TECHNICAL SUPPORT (TS) AND RELAYED THAT THE TECHNICIANS WERE LIKELY UNCAPPING THE APTIMA COMBO 2 (AC2) AND APTIMA TRICHOMONAS VAGINALIS (ATV) READY MADE REAGENT (RMR) BOTTLES AT ROOM TEMPERATURE. CUSTOMER SPECIFIED THAT TWO TECHNICIANS WENT TO URGENT CARE FOR PAIN IN THEIR RIGHT HAND AND RECEIVED PHYSICAL THERAPY AS MEDICAL TREATMENT. HOLOGIC EXAMINED THE RETENTION MATERIAL AND FOUND THE REAGENTS TO FALL WITHIN THE MANUFACTURING SPECIFICATIONS FOR TORQUE VALUES. THE CUSTOMER WORKFLOW WAS NOT PROVIDED TO HOLOGIC (I.E. NUMBER OF BOTTLES THE TECHNICIAN UNCAPPED WITHIN A SPECIFIED TIME PERIOD). HOLOGIC PERFORMED A RISK ASSESSMENT. THERE ARE NO OTHER COMPLAINTS WHEREIN A CUSTOMER INDICATED A STRAIN INJURY UNCAPPING THESE REAGENTS. A RETENTION CHECK OF PRODUCT FOUND REAGENTS TO FALL WITHIN THE MANUFACTURING SPECIFICATIONS FOR TORQUE VALUES. THE CUSTOMER HAS NOT PROVIDED FURTHER INFORMATION ABOUT THE TECHNICIANS.

Description of Event or Problem

ON AUGUST 6, 2024, CUSTOMER RELAYED TO HOLOGIC THAT IN JUNE 2024 TWO TECHNICIANS WENT TO URGENT CARE FOR HAND/WRIST PAIN FOR THE RIGHT HAND, ALLEGEDLY CAUSED BY THE UNCAPPING OF HOLOGIC READY-MADE-REAGENT (RMR) BOTTLES. THE TECHNICIANS SUBSEQUENTLY RECEIVED PHYSICAL THERAPY.