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Advia Centaur XP and CP System and Advia Centaur System (2014-06-04)
- Starting date:
- June 4, 2014
- Posting date:
- July 3, 2014
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type II
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public, Healthcare Professionals, Hospitals
- Identification number:
- RA-40287
Recalled Products
A) Advia Centaur System - Troponin I Ultra (TNI-ULTRA) Assay
B) Advia Centaur XP System - Troponin I Ultra (TNI-ULTRA) Assay
C) Advia Centaur CP System - Troponin I Ultra (TNI-ULTRA) Assay
Reason
Siemens healthcare diagnostic has confirmed through internal investigation of lot 084, that the solid phase in some of the lot 084 TNI-ULTRA readypack is darker in appearance.
Affected products
A) Advia Centaur System - Troponin I Ultra (TNI-ULTRA) Assay
Lot or serial number
Kit lots ending in 078
Kit lots ending in 079
Kit lots ending in 082
Kit lots ending in 083
Kit lots ending in 084
Model or catalog number
02789602
02790309
Companies
- Manufacturer
-
Siemens Healthcare Diagnostics Inc.
511 Benedict Ave.
Tarrytown
10591
New York
UNITED STATES
B) Advia Centaur XP System - Troponin I Ultra (TNI-ULTRA) Assay
Lot or serial number
Kit lots ending in 078
Kit lots ending in 079
Kit lots ending in 082
Kit lots ending in 083
Kit lots ending in 084
Model or catalog number
02789602
02790309
Companies
- Manufacturer
-
Siemens Healthcare Diagnostics Inc.
511 Benedict Ave.
Tarrytown
10591
New York
UNITED STATES
C) Advia Centaur CP System - Troponin I Ultra (TNI-ULTRA) Assay
Lot or serial number
Kit lots ending in 078
Kit lots ending in 079
Kit lots ending in 082
Kit lots ending in 083
Kit lots ending in 084
Model or catalog number
02789602
02790309
Companies
- Manufacturer
-
Siemens Healthcare Diagnostics Inc.
511 Benedict Ave.
Tarrytown
10591
New York
UNITED STATES