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ABX Pentra 400 Clinical Chemistry Systems (2014-09-26)
- Starting date:
- September 26, 2014
- Posting date:
- November 26, 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, Hospitals
- Identification number:
- RA-42591
Recalled Products
A) ABX Pentra 400 Clinical Chemistry System - MultiCal
B) ABX Pentra 400 Clinical Chemistry System Controls
Reason
This recall has been initiated due to the potential that, it was observed that creatinine rate blank method calibrator and control results were reporting values lower than target values indicated in the associated ABX Pentra Multical, N control and P control annexes. Horiba has reassigned the target values and updated annexes for the products and lot numbers.
Affected products
A) ABX Pentra 400 Clinical Chemistry System - MultiCal
Lot or serial number
1204103
1304901
1304902
Model or catalog number
A11A01652
Companies
- Manufacturer
-
Horiba ABX, Parc Euromedecine
rue Du Caducee - BP 7290, Cedex 4,
Montpellier
34184
FRANCE
B) ABX Pentra 400 Clinical Chemistry System Controls
Lot or serial number
1300602
1300802
1300803
Model or catalog number
A11A01653
A11A01654
Companies
- Manufacturer
-
Horiba ABX, Parc Euromedecine
rue Du Caducee - BP 7290, Cedex 4,
Montpellier
34184
FRANCE