MalfunctionGRP
REMEL XPECT INFLUENZA A&B KIT
Received Apr 19, 2006 · Event occurred Apr 18, 2006
Report MW1038748 · MDR key 709241
Product problems
- False Positive Result
Patient
*
- Unknown (for use when the patient's condition is not known)
Narrative
Description of Event or Problem
OUR HOSPITAL USED REMEL XPECT INFLUENZA A&B TESTING SCREEN. YESTERDAY WE HAD OUR SECOND FALSE POSITIVE REACTION. LAST WEEK WE ENCOUNTERED ANOTHER INCIDENT WHERE THE TEST SAYS INFLUENZA IS PRESENT BUT WHEN YOU REPEAT THE TEST IT IS NEGATIVE. THIS WAS REPORTED TO THE CO. REMEL IS INVESTIGATING. WE ISSUED AMENDED REPORTS ON EACH PT.