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Engen Automated Sample Handling System (2014-04-11)
- Starting date:
- April 11, 2014
- Posting date:
- April 30, 2014
- 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-39265
Recalled products
Engen Automated Sample Handling System
Reason
In Engen systems with TC-Automation (TCA) software version 2.6, version 3.2 and version 3.5 configured with bypass modules for Advia Centaur, Abbott Architect, Vitros and/or Tosoh Aia systems, a sample tube carrier being released in the bypass module may not be detected and, therefore, the next sample to be metered may not advance for processing. No error message will be posted if this occurs. The bypass module will stop processing samples indefinitley until an operator detects the issue and intervenes.
Affected products
Engen Automated Sample Handling System
Lot or serial number
JIM340432
JIM340814
JIM341055
JIM341130
Model or catalog number
Engen
Companies
- Manufacturer
-
Thermo Fisher Scientific Oy
P.O. Box 100, Ratastie 2
Vantaa
01621
FINLAND