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Health product recall

Indiko and Indiko Plus (2014-02-28)

Starting date:
February 28, 2014
Posting date:
February 16, 2015
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-43693

Recalled Products

A) Indiko

B) Indiko Plus

Reason

A new cuvette does not always replace the old used cuvette from the incubator. As a result, a new sample might be dispensed to an already used cuvette causing an erroneous result.

Affected products

A) Indiko

Lot or serial number

Not applicable

Model or catalog number

98630000-0 INDIKO

Companies
Manufacturer
Thermo Fisher Scientific Oy
P.O. Box 100, Ratastie 2
Vantaa
01621
FINLAND

B) Indiko Plus

Lot or serial number

Not applicable

Model or catalog number

9864 0000-0

Companies
Manufacturer
Thermo Fisher Scientific Oy
P.O. Box 100, Ratastie 2
Vantaa
01621
FINLAND