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ADVIA CENTAUR SYSTEM-VITAMIN D TOTAL (VITD) REAGENTS
- Starting date:
- October 5, 2016
- 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-60674
Affected Products
Reason
Siemens Healthcare Diagnostics has confirmed a change in bias between serum and plasma specimen tubes with the ADVIA CENTAUR VITAMIN D ASSAY as compared to instructions for use (IFU). Newly evaluated data demonstrate a deming regression slope between 0.93 and 0.95 for plasma samples as compared to serum samples whereas, the specimen collection comparison data provided in the IFU indicates a linear regression slope of up to 1.09.
Affected products
ADVIA CENTAUR SYSTEM-VITAMIN D TOTAL (VITD) REAGENTS
Lot or serial number
All lots.
Model or catalog number
10699201
10699533
Companies
- Manufacturer
-
Siemens Healthcare Diagnostics Inc.
511 Benedict Ave
Tarrytown
10591
New Jersey
UNITED STATES