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