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ABX Pentra 400 (2016-01-18)
- Starting date:
- January 18, 2016
- Posting date:
- February 12, 2016
- 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-57112
Affected Products
- CHOLESTEROL CP 380T
- ABX PENTRA 400 CLINICAL CHEMISTRY SYSTEM
- uric acid cp 220T
- LACTIC ACID 260ML
Reason
N-acetylcysteine present in the blood of patients treated for paracetamol overdose can interfere with the Trinder reaction that uses hydrogen peroxide catalytic on aminoantipyrine and phenol, and can produce falsely low results with the reagents using the Trinder reaction method.
Affected products
A. CHOLESTEROL CP 380T
Lot or serial number
Not Applicable
Model or catalog number
A11A01634
Companies
- Manufacturer
-
Horiba ABX, Parc Euromedecine
rue Du Caducee - BP 7290, Cedex 4,
Montpellier
34184
FRANCE
B. ABX PENTRA 400 CLINICAL CHEMISTRY SYSTEM
Lot or serial number
Not Applicable
Model or catalog number
A11A01640
Companies
- Manufacturer
-
Horiba ABX, Parc Euromedecine
rue Du Caducee - BP 7290, Cedex 4,
Montpellier
34184
FRANCE
C. uric acid cp 220T
Lot or serial number
Not Applicable
Model or catalog number
A11A01670
Companies
- Manufacturer
-
Horiba ABX, Parc Euromedecine
rue Du Caducee - BP 7290, Cedex 4,
Montpellier
34184
FRANCE
D. LACTIC ACID 260ML
Lot or serial number
Not Applicable
Model or catalog number
A11A01721
Companies
- Manufacturer
-
Horiba ABX, Parc Euromedecine
rue Du Caducee - BP 7290, Cedex 4,
Montpellier
34184
FRANCE