Product Wiki · Recalls · Health Canada — Medical Devices

Advia Centaur CP System - Calibrator (field correction) — recall 48391

Health Canada — Medical Devices · Canada · 2012-09-03 · Type III

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Agency
Health Canada — Medical Devices
Recall identifier
48391
Date of alert
2012-09-03
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: Siemens is conducting a field correction for Advia Centaur System Calibrator B Lot 40 and below for use with Advia Centaur Prolactin Assay on the Advia Centaur CP System. Siemens has confirmed analytical sensitivity of greater than the 0.3 ng/ml described in the instructions for use with multiple Advia Centaur Prolactin Reagent Lots and multiple Calibrator B Lots when run on the Advia Centaur CP only.
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/advia-centaur-cp-system-calibr

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