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Advia Centaur Insulin Assays (2017-04-10)
- Starting date:
- April 10, 2017
- Posting date:
- May 2, 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-63154
Affected Products
A. Advia Centaur System - Insulin Assay
B. Advia Centaur CP System - Insulin Assay
Reason
Siemens has identified that current in-date lots of Advia Centaur Systems Insulin Assay, recover approximately 40% higher than the world health organization (WHO) 1st IRP 66/304 standardization based on slope values. The slope value was 1.40 on the Advia Centaur and 1.42 on the Advia Centaur CP. Corrected (re-standardized) lots will be available by May 2017.
Affected products
A. Advia Centaur System - Insulin Assay
Lot or serial number
04177173
11090173
11587A59
11606A67
11615A70
11624A74
16546174
61612169
75853169
90517170
Model or catalog number
02230141
04618899
Companies
- Manufacturer
-
Siemens Healthcare Diagnostics Inc.
511 Benedict Ave
Tarrytown
10591
UNITED STATES
B. Advia Centaur CP System - Insulin Assay
Lot or serial number
04177173
11090173
11587A59
11606A67
11615A70
11624A74
16546174
61612169
75853169
90517170
Model or catalog number
02230141
04618899
Companies
- Manufacturer
-
Siemens Healthcare Diagnostics Inc.
511 Benedict Ave
Tarrytown
10591
UNITED STATES