inforMED
MalfunctionLIO

ORAQUICK ADVANCE HIV 1 & 2 RAPID TEST KIT

Received Nov 5, 2007

Report MW5004348 · MDR key 939451

Device

Generic name

None

Manufacturer

Orasure Tec

Model number

*

Catalog number

*

Lot number

6604579

Product problems

  • False Positive Result

Patient

*

  • Unknown (for use when the patient's condition is not known)

Narrative

Description of Event or Problem

REPORTER STATES THAT THERE HAS BEEN AN INCREASED NUMBER OF FALSE POSITIVE TEST RESULTS WHEN ORAL FLUIDS ARE USED.