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Advia Centaur CP System - Calibrator
- Starting date:
- October 11, 2012
- Posting date:
- October 29, 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 (GP), Healthcare Professionals, Hospitals
- Identification number:
- RA-15169
Recalled Products:
Advia Centaur CP System - Calibrator
Reason
There is analytical sensitivity greater than 0.50 ng/ml described in the instructions for use when the affected Calibrator C lots are used with Advia Centaur Ferritin on the Advia Centaur CP System only. This does not apply to the Advia Centaur or Advia Centaur XP systems.
Affected products
Advia Centaur CP System - Calibrator
Lot or serial number
- 82069A22
- 82909A22
- 82946A22
- 5268A22
- 87430B22
- 88921B22
- 89730B22
- 90884B22
- 95232A23
Model or catalog number
- 03439230
- 06567787
- 672182005
Companies
- Manufacturer
- Siemens Healthcare Diagnostics Products Limited