VITROS 3600 Immunodiagnostic System, VITROS 5600 Integrated System, VITROS XT 7600 Integrated System (2019-02-21)
- Starting date:
- February 21, 2019
- Posting date:
- March 8, 2019
- 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-69250
Affected Products
- VITROS 3600 Immunodiagnostic System
- VITROS 5600 Integrated System
- VITROS XT 7600 Integrated System
Reason
A luminometer malfunction may occur after the system is shut down and restarted, due to the luminometer signal board parameters incorrectly reverting to the default settings. If this occurs, users will not be able to process any microwell assays until service is performed. In this scenario, an ortho-trained service representative must be dispatched to resolve the malfunction.
Affected products
A. VITROS 3600 Immunodiagnostic System
Lot or serial number
Serial# 36001160 and higher.
Model or catalog number
680 2783
Companies
- Manufacturer
-
Ortho-Clinical Diagnostics Inc.
100 Indigo Creek Drive
Rochester, New York
14626
UNITED STATES
B. VITROS 5600 Integrated System
Lot or serial number
Serial# 56003270 and higher.
Model or catalog number
680 2413
Companies
- Manufacturer
-
Ortho-Clinical Diagnostics Inc.
100 Indigo Creek Drive
Rochester, New York
14626
UNITED STATES
C. VITROS XT 7600 Integrated System
Lot or serial number
Serial# 76000108 and higher.
Model or catalog number
684 4461
Companies
- Manufacturer
-
Ortho-Clinical Diagnostics Inc.
100 Indigo Creek Drive
Rochester, New York
14626
UNITED STATES