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ABX PENTRA Magnesium RTU (2014-09-26)

Starting date:
September 26, 2014
Posting date:
October 10, 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
Identification number:
RA-41755

Recalled Products

ABX PENTRA Magnesium RTU

Reason

Potential that, customers running the Magnesium RTU Assay on the ABX PENTRA 400 Chemistry Analyzers that on-board stability has been updated. User will be unable to calibrate the Magnesium RTU Assay after 1 day of on-board (on instrument use), the control will be out of range at values lower than target values. The result reported using this failed calibration will be flagged "cal_error" displayed on the results with a "C".

Affected products

ABX PENTRA Magnesium RTU

Lot or serial number

All lots.

Model or catalog number

A11A01646

Companies
Manufacturer
Horiba ABX, Parc Euromedecine
rue Du Caducee - BP 7290, Cedex 4,
Montpellier
34184
FRANCE