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Advia Centaur Systems - Br (27.29) Asssays (2017-03-14)
- Starting date:
- March 14, 2017
- Posting date:
- April 4, 2017
- 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-62898
Affected Products
A. Advia Centaur System - Br (27.29) Assay
B. Advia Centaur Cp System - Br (27.29) Assay
Reason
Siemens Healthcare Diagnostics has confirmed that the Advia Centaur BR (ca 27.29) assay does not dilute linearly when used with multi-diluent 1 kit lots ending in 2577 and all future lots until further notice. When diluted, some samples over-recover the expected neat value by greater than 120%.
Affected products
A. Advia Centaur System - Br (27.29) Assay
Lot or serial number
All lots
Model or catalog number
3896216
Companies
- Manufacturer
-
Siemens Healthcare Diagnostics Inc.
511 Benedict Ave
Tarrytown
10591
UNITED STATES
B. Advia Centaur Cp System - Br (27.29) Assay
Lot or serial number
All lots
Model or catalog number
3896216
Companies
- Manufacturer
-
Siemens Healthcare Diagnostics Inc.
511 Benedict Ave
Tarrytown
10591
UNITED STATES