Health product recall

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

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

A. VITROS 3600 Immunodiagnostic System-Instrument

Lot or serial number
  • SW V3.3.3 & below.
Model or catalog number
  • 680 2783
  • 680 2914
Companies
Manufacturer

Ortho-Clinical Diagnostics Inc.

100 Indigo Creek Drive

Rochester

14626

New York

UNITED STATES

B. VITROS 5600 Integrated System-Instrument

Lot or serial number
  • SW V3.3.3 & below.
Model or catalog number
  • 680 2413
  • 680 2915
Companies
Manufacturer

Ortho-Clinical Diagnostics Inc.

100 Indigo Creek Drive

Rochester

14626

New York

UNITED STATES

C. VITROS XT 7600 Integrated System

Lot or serial number
  • SW V3.3.3 & below.
Model or catalog number
  • 684 4461
Companies
Manufacturer

Ortho-Clinical Diagnostics Inc.

100 Indigo Creek Drive

Rochester

14626

New York

UNITED STATES