ARCHITECT I SYSTEM - EBV VCA IgM Calibrator (2020-11-03)

Starting date:

November 3, 2020

Posting date:

November 13, 2020

Type of communication:

Medical Device Recall

Subcategory:

Medical Device

Hazard classification:

Type II

Source of recall:

Health Canada

Issue:

Medical Devices

Audience:

General Public, Healthcare Professionals, Hospitals

Identification number:

RA-74305

Last updated:
2020-11-13

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  Reason
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  Affected products

Affected Products

ARCHITECT I SYSTEM -  EBV VCA IgM Calibrator

Reason

Abbott has identified the ARCHITECT EBV VCA IgM Calibrator lot 08159BE00 may show reduced RLU (Relative Light Units) signal. This reduced RLU signal may cause a decrease in cutoff RLU values in assay calibration resulting in:

• upward shift in quality control S/CO values
• non-reactive to false grayzone patient results in the range of 0.50 - 0.56 S/CO
• grayzone to false reactive patient results in the range of 1.00 - 1.13 S/CO

The effect of decreased cutoff RLU values is observed when using the ARCHITECT EBV VCA IgM Calibrator lot 08159BE00 and is independent from the ARCHITECT EBV VCA IgM Reagent lot used.

Affected products