Product Wiki · Recalls · Health Canada — Medical Devices

ABX Pentra 400 Clinical Chemistry Systems (2014-09-26) — recall 52748

Health Canada — Medical Devices · Canada · 2014-11-26 · Type III

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Agency
Health Canada — Medical Devices
Recall identifier
52748
Date of alert
2014-11-26
Country / jurisdiction
Canada
Risk level
Type III
Risk type
recall
Product category
Medical devices
Product type
Medical devices
Notice status
Archived by the issuing authority — kept for reference
Reported risk: 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.
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/abx-pentra-400-clinical-chemis

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