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Engen Laboratory Automation System
- Starting date:
- March 9, 2017
- Posting date:
- March 31, 2017
- 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-62858
Reason
Ortho Clinical Diagnostics (Ortho) has initiated this recall in regard to a software anomaly where the TCAutomation Software may send incorrect information to a VITROS system through the InOut communication interface. This event can cause an unintended sample to be moved into the bypass aspiration position and aspirated, and results to be mis-associated with the wrong patient sample ID without the operator being notified. The InOut communication interface is currently used by all Engen Systems.
Affected products
Engen Laboratory Automation System
Lot or serial number
- J16XQH4J
- J1HX7S4J
- J41BCY4J
- J953234
- J953244
- JCT20Q3J
Model or catalog number
- ENGEN
Companies
- Manufacturer
-
Thermo Fisher Scientific Oy
P.O. Box 100, Ratastie 2
Vantaa
01621
FINLAND