inforMED
InjuryMLM

IMX TACROLIMUS II REAGENT PACK

Received Oct 20, 2005

Report 1415939-2005-00026 · MDR key 642158

Device

Generic name

Meia For The Measurement Of Tacrolimus

Model number

NA

Catalog number

3C10-20

Lot number

30496M100

Product problems

  • Incorrect Or Inadequate Test Results

Patient

UNKNOWN

  • Host-Tissue Reaction

Narrative

Description of Event or Problem

THE ACCOUNT STATES PHYSICIANS ARE QUESTIONING THE VARIABILTIY IN PT RESULTS GENERATED ON THE IMX TACROLIMUS II ASSAY. A CONFERENCE CALLED WAS HELD IN 2005 REGARDING THIS ISSUE AND REPRESENTATIVES FROM THE ACCOUNT AND ABBOTT LABORATORIES WERE IN ATTENDANCE. THE ACCOUNT STATED THAT THERE HAS BEEN AN INCREASE IN KIDNEY REJECTION RATE IN PTS. NO SPECIFIC PT INFORMATION WAS GIVEN.