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ABX PENTRA 400 CLINICAL CHEMISTRY SYSTEM (2016-02-19)
- Starting date:
- February 19, 2016
- Posting date:
- May 31, 2016
- 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-58692
Affected products
A. ABX PENTRA 400 CLINICAL CHEMISTRY SYSTEM
Reason
A malfunction with reagent dispensing on the ABX Pentra 400 (version 5.0.8 & lower) and Pentra C400 (version 1.1.2 & lower) chemistry analyzers for the applications using 2 or more reagents in their assay reactions. Could potentially lead to falsely low or falsely high results.
Affected products
A. ABX PENTRA 400 CLINICAL CHEMISTRY SYSTEM
Lot or serial number
361014384
Model or catalog number
P4000000NUA1
Companies
- Manufacturer
-
Horiba ABX, Parc Euromedecine
rue Du Caducee - BP 7290, Cedex 4,
Montpellier
34184
FRANCE