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

Subcategory:

Medical Device

Hazard classification:

Type I

Source of recall:

Health Canada

Issue:

Medical Devices

Audience:

General Public, Healthcare Professionals, Hospitals

Identification number:

RA-67358

• Reason
• Affected products

Affected products

ARCHITECT I Sytem - EBV VCA IgM Reagent Kit

Reason

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