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Engen Laboratory Automation System
- Starting date:
- April 27, 2017
- Posting date:
- June 5, 2017
- 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-63468
Reason
Ortho Clinical Diagnostics (Ortho) has identified the potential for delay in reporting of results due to patient samples being routed to an unintended location when samples are reintroduced back onto the Engen track for specific Engen laboratory automation system configurations due to a software issue.
Affected products
Engen Laboratory Automation System
Lot or serial number
J1HX7S4J
J953244
Model or catalog number
ENGEN
Companies
- Manufacturer
-
Thermo Fisher Scientific Oy
P.O. Box 100, Ratastie 2
Vantaa
01621
FINLAND