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Indiko System and Indiko Plus (2013-12-13)
- Starting date:
- December 13, 2013
- Posting date:
- November 25, 2016
- 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-61202
Affected Products
- A. Indiko System
- B. Indiko Plus
Reason
It was reported on October 2013 that the report-to-file function does not work properly and there is potential for sample ID and test results to be mismatched. Investigation of the issue by Thermo Fisher Scientific revealed that the report-to-file function was not being used in Canada at the time. The software on Canadian analyzers was updated at the time of the reported incident.
Affected products
A. Indiko System
Lot or serial number
863000090129
Model or catalog number
- 98630000-0
- 98631000-9
Companies
- Manufacturer
-
Thermo Fisher Scientific Oy
P.O. Box 100, Ratastie 2
Vantaa
01621
FINLAND
B. Indiko Plus
Lot or serial number
864000090124
Model or catalog number
98640000-9
98641000-0
Companies
- Manufacturer
-
Thermo Fisher Scientific Oy
P.O. Box 100, Ratastie 2
Vantaa
01621
FINLAND