Health product recall

ARCHITECT I Sytem - EBV VCA IgM Reagent Kit (2018-07-26)

Starting date:
July 26, 2018
Posting date:
August 2, 2018
Type of communication:
Medical Device Recall
Medical Device
Hazard classification:
Type I
Source of recall:
Health Canada
Medical Devices
General Public, Healthcare Professionals, Hospitals
Identification number:

Affected products

ARCHITECT I Sytem - EBV VCA IgM Reagent Kit


ARCHITECT EBV VCA IgM Reagent lots 85278LI00 and 85279LI00 show reduced RLU signals with 4 distributed ARCHITECT EBV VCA IgM Calibrator lots (71146LI00, 73014LI00, 79576LI00 or 83327LI00), leading to decreased cut-off RLU values in assay calibration.

The decreased cut-off RLU values of maximum 20% will result into

  • Quality Control S/CO values shifting up
  • false grayzone patient results in the range of 0.50-0.60 S/CO
  • false reactive patient results in the range 1.00-1.20 S/CO

Cause investigation discovered that the reduced signals are driven by the microparticle component of the reagent, specifically by one lot of microparticle concentrate. Estimated Date of completion: October 2018.

ARCHITECT EBV VCA IgM reagent lots 85278LI00 and 85279LI00 have been placed on Quality Hold on 20-Apr-2018 (QH1019-2018).

Affected products

ARCHITECT I Sytem - EBV VCA IgM Reagent Kit

Lot or serial number
  • 85278LI00
  • 85279LI00
Model or catalog number
  • 3P66-25
  • 3P66-35

Abbott GmbH and Co. K.G.

Max Planck Ring 2