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Health product recall

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   

  1. CHOLESTEROL CP 380T
  2. ABX PENTRA 400 CLINICAL CHEMISTRY SYSTEM
  3. uric acid cp 220T
  4. 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