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
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
ARCHITECT I Sytem - EBV VCA IgM Reagent Kit
Lot or serial number
- 85278LI00
- 85279LI00
Model or catalog number
- 3P66-25
- 3P66-35
Companies
- Manufacturer
-
Abbott GmbH and Co. K.G.
Max Planck Ring 2
Wiesbaden
65205
GERMANY