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A) Vitros 5600 Integrated System - Software B) Vitros 5600 Integrated System - Software
- Starting date:
- April 27, 2012
- Posting date:
- May 28, 2012
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type II
- Source of recall:
- Health Canada
- Identification number:
- RA-73912
Reason
OCD has identified an anomaly with Vitros 5600 Integrated System Software Version 1.6 and below. Internal testing determined that under very specific conditions, a surfactant addition may inadvertently be added to a Cuvetip or an empty Cuevtip Position for which it was not intended. Please refer to the customer letter for details of the specific conditions in which this event may occur.Affected products
A) Vitros 5600 Integrated System - Software B) Vitros 5600 Integrated System - Software
Lot or serial number
A) Software Version 1.6 and below B) Software Version 1.6 and below
Model or catalog number
A) 6802864 B) 6802864
Companies
- Manufacturer
- Ortho-Clinical Diagnostics Inc.