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Health product recall

Accu-chek Inform II + RF Meter (2014-08-25)

Starting date:
August 25, 2014
Posting date:
September 3, 2014
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-41247

Recalled Products

Accu-chek Inform II + RF Meter

Reason

The manufacturer has identified an issue that makes the meter revert to the "test stand mode" after being used. This triggers the need to switch the meter off and when turned on again leaves the meter unusable. No false result could be generated.

Affected products

Accu-chek Inform II + RF Meter 

Lot or serial number

S/A## UU14000000 TO UU14029876

Model or catalog number

05060303001

Companies
Manufacturer

Roche Diagnostics GmbH

Sandhofer Strasse 116

Mannheim

68305

GERMANY