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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