APTIMA URINE SPECIMEN COLLECTION KIT FOR MALE AND FEMALE URINE SPECIMENS
Received Jun 16, 2026 · Event occurred May 27, 2026
Report 2024800-2026-00034 · MDR key 25522051
Device
Product problems
- Insufficient Device Problem Information
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
ON (B)(6) 2026, A CUSTOMER IN CANADA CONTACTED HOLOGIC TO REPORT ERGONOMIC CONCERNS ON THEIR OPERATORS. ON (B)(6) 2026, HOLOGIC RECEIVED CLARIFICATION THAT THREE OPERATORS AT THE CUSTOMER SITE SUSTAINED ERGONOMIC INJURIES DUE TO SPECIMEN RACK HANDLING ON THE INSTRUMENT, ADDING AND/OR REMOVING SAMPLE TUBES, AND CAPPING OR UNCAPPING SPECIMEN TUBES. THE INJURIES REPORTED INCLUDED TINGLING AND NUMBNESS IN THE HANDS, PAIN IN THE ELBOW, AND A HAND INJURY. DUE TO THESE INJURIES, THE OPERATORS WERE UNABLE TO PERFORM SOME OF THESE LAB TASKS. THE CUSTOMER REPORTED THE INJURIES INTERNALLY TO THE INJURY NEAR MISS (INM) SHARED HEALTH AND EXTERNALLY TO THE WORKERS¿ COMPENSATION BOARD (WCB). THE CUSTOMER DID NOT PROVIDE FURTHER DETAILS ABOUT THE INJURIES, ANY MEDICAL INTERVENTION OR THE MEDICAL STATUS OF THE INJURED OPERATORS.
Additional Manufacturer Narrative
THE AVERAGE TESTING THROUGHPUT FOR THIS CUSTOMER SITE IS APPROXIMATE 500 ¿ 700 SAMPLES PER DAY BASED ON AVERAGE APTIMA SPECIMEN TUBES. AS OF (B)(6) 2026, THE CUSTOMER DID NOT VERIFY WHETHER MEDICAL PREVENTION WAS PROVIDED OR THE MEDICAL STATUS OF THE INJURED OPERATORS. THE PANTHER/ PANTHER FUSION SYSTEM OPERATOR¿S MANUAL RECOMMENDS, ¿TO REDUCE THE RISK OF DEVELOPING STRESS INJURIES, TAKE FREQUENT BREAKS FROM REPETITIVE TASKS LIKE OPENING AND CLOSING TUBES.¿ REPETITIVE STRAIN INJURIES (RSIS) ARE RELATED TO MULTIPLE FACTORS INCLUDING WORKSTATION SET UPS, MULTIPLE JOBS PERFORMED BY ONE OPERATOR, ACTIVITIES OUTSIDE OF WORK, OR GENERAL SUSCEPTIBILITY PROFILES OF INDIVIDUALS. H3 OTHER TEXT : OTHER.