inforMED

ORASURE

Received Apr 5, 2002

Report MW4003270 · MDR key 387890

Device

Generic name

Hiv Test

Model number

NI

Catalog 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.