ORASURE
Received Apr 5, 2002
Report MW4003270 · MDR key 387890
Device
Generic name
Hiv Test
Manufacturer
Epitome Pharmaceuticals LtdModel number
NICatalog number
NI
Lot number
NI
Product problems
- Expiration Date Error
Patient
NO INFO
- Therapy/non-surgical treatment, additional
Narrative
Description of Event or Problem
CLIENT HAD AN HIV TEST USING ORASURE. THE EXPIRATION DATE ON THE OUTSIDE OF THE TEST KIT HAD EXPIRED, BUT THE DATE INSIDE THE KIT HAD NOT. FACILITY CONTACTED THE CO AND WAS ASSURED THAT THE KIT WAS FINE TO BE USED ON PTS. THE RESULT CAME BACK, "ORAL FLUID HIV AB ELISA POSITIVE". THE ORAL FLUID HIV-1 WESTERN BLOT WAS "UNSUITABLE FOR ANALYSIS" DUE TO THE EXPIRATION DATE. THE PT SUBSEQUENTLY HAD A NEGATIVE BLOOD TEST. RPTR FEELS THERE SHOULD NOT BE MORE THAN 1 EXPIRATION DATE ON THE TESTING MATERIAL. THE PT SHOULD NEVER HAVE BEEN SUBJECTED TO THE EMOTIONAL DISTRESS THEY SUFFERED. ACCORDING TO RPTR THE CO GIVES OUT INACCURATE INFO.