VITROS 3600 Immunodiagnostic System-Instrument, 5600 Integrated System-Instrument & XT 7600 Integrated System (2020-05-26)

Starting date:

May 26, 2020

Posting date:

June 19, 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-73349

Last updated: 2020-06-19

• 
  Reason
• 
  Affected products

Affected Products

1. VITROS 3600 Immunodiagnostic System-Instrument
2. VITROS 5600 Integrated System-Instrument
3. VITROS XT 7600 Integrated System

Reason

Current functionality automatically updates these values for plasma when serum is updated. Both serum and plasma user modifications in the options & configuration - review/edit calibrations - review assay data screen should then be marked with M1 to ensure the modifications are retained when retain configuration is used during add load. Internal testing identified a software anomaly which occurs if the qualitative result text and/or qualitative range settings are modified by the operator for serum, the corresponding values are updated for plasma, however the M1 code is not assigned to plasma. Therefore, after loading an add and selecting retain configuration, the modified qualitative result text and qualitative ranges are retained for serum, but the plasma qualitative result text and qualitative ranges incorrectly revert to the default values validated by ortho and recommended in the vitros immunodiagnostic products instructions for use (IFU). No other parameters are affected by this issue.

Affected products