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Advia Centaur CP System - Calibrator (field correction)
- Starting date:
- August 10, 2012
- Posting date:
- September 3, 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-15566
Recalled Products
A. Advia Centaur CP System - Calibrator
Reason
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.
Affected products
A. Advia Centaur CP System - Calibrator
Lot or serial number
- 79354A30
- 81892B30
- 82815B30
- 83401C30
- 86191A40
- 89717C40
Model or catalog number
652707
Companies
- Manufacturer
- Siemens Healthcare Diagnostics Inc.