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Health product recall

Advia Centaur Systems – Cortisol Assay

Starting date:
March 8, 2012
Posting date:
April 2, 2012
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-26275

Recalled Products

  1. Advia Centaur XP System – Cortisol Assay
  2. Advia Centaur System – Cortisol Assay
  3. Advia Centaur CP System – Cortisol Assay

Reason

All kit lots of reagent lots xxxxx254 through xxxxx257 do not meet onboard stability and calibration interval claims. Customers may notice an increase in their quality control values through routine monitoring.

Affected products

A. Advia Centaur XP System – Cortisol Assay

Lot or serial number

More than 10 Numbers, Contact manufacturer

Model or catalog number
  • 04610049
  • 04610138
  • 04611509
Companies
Manufacturer
Siemens Canada Limited

B. Advia Centaur System – Cortisol Assay

Lot or serial number

More than 10 Numbers, Contact manufacturer 

Model or catalog number
  • 04610049
  • 04610138
  • 04611509
Companies
Manufacturer
Siemens Canada Limited

C. Advia Centaur CP System – Cortisol Assay

Lot or serial number

More than 10 Numbers, Contact manufacturer

Model or catalog number
  • 04610049
  • 04610138
  • 04611509
Companies
Manufacturer
Siemens Canada Limited