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Vitros 5600 Integrated Systems (2014-09-30)
- Starting date:
- September 30, 2014
- Posting date:
- October 9, 2014
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type III
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public, Healthcare Professionals, Hospitals
- Identification number:
- RA-41709
Recalled Products
A) Vitros 5600 Integrated System (Device Licence #78571)
B) Vitros 5600 Integrated System (Device Licence #80701)
Reason
Ortho Clinical Diagnostics (OCD) has identified an anomaly with Vitros system software version 3.1. Internal testing confirmed that when using calibrator barcode labels supplied with Vitros chemistry products calibrator kit 2, calibration may not occur under specific circumstances. Consignees are being advised not to use the calibrator barcode labels for Vitros calibrator kit 2 until this anomaly is resolved in a future version of software.
Affected products
A) Vitros 5600 Integrated System (Device Licence #78571)
Lot or serial number
56000576
Model or catalog number
680 2413
Companies
- Manufacturer
-
Ortho-Clinical Diagnostics, Inc.
100 Indigo Creek Drive
Rochester
14626
New York
UNITED STATES
B) Vitros 5600 Integrated System (Device Licence #80701)
Lot or serial number
56000576
Model or catalog number
680 2413
Companies
- Manufacturer
-
Ortho-Clinical Diagnostics, Inc.
100 Indigo Creek Drive
Rochester
14626
New York
UNITED STATES