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VITROS System Softwares (2015-11-04)
- Starting date:
- November 4, 2015
- 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-55978
Affected Products
A. VITROS 3600 System Software
B. VITROS 5600 System Software
C. VITROS 5600 System Software
D. VITROS 3600 System Software
Reason
Ortho Clinical Diagnostics initiated this recall notification due to a software anomaly in which, under very specific circumstances, the temperature in the well wash module of the Vitros 3600 Immunodiagnostic System and Vitros 5600 Integrated System may be out of range without alerting the operator.
Affected products
A. VITROS 3600 System Software
Lot or serial number
36000130
36000264
36000627
36000773
Model or catalog number
680 2866
Companies
- Manufacturer
-
Ortho-Clinical Diagnostics, Inc.
100 Indigo Creek Drive
Rochester
14626
New York
UNITED STATES
B. VITROS 5600 System Software
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
680 2864
Companies
- Manufacturer
-
Ortho-Clinical Diagnostics, Inc.
100 Indigo Creek Drive
Rochester
14626
New York
UNITED STATES
C. VITROS 5600 System Software
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
680 2864
Companies
- Manufacturer
-
Ortho-Clinical Diagnostics, Inc.
100 Indigo Creek Drive
Rochester
14626
New York
UNITED STATES
D. VITROS 3600 System Software
Lot or serial number
36000130
36000264
36000627
36000773
Model or catalog number
680 2866
Companies
- Manufacturer
-
Ortho-Clinical Diagnostics, Inc.
100 Indigo Creek Drive
Rochester
14626
New York
UNITED STATES