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ADVIA Centaur System (2015-05-21)
- Starting date:
- May 21, 2015
- Posting date:
- June 10, 2015
- 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-53729
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 diagnostics has observed a system-to-system bias between the TnI-Ultrat assay on the ADVIA Centaur CP and ADVIA Centaur/ADVIA Centaur XP/ADVIA Centaur XPT systems with the ADVIA Centaur CP generating lower results than the ADVIA Centaur/ ADVIA Centaur XP / ADVIA Centaur XPT system. This observation impacts customers who use the TnI-Ultrat assay on both the ADVIA centaur CP and ADVIA Centaur/ ADVIA centaur XP/ ADVIA Centaur XPT systems interchangeably when interpreting serial testing in patient samples. This communication does not impact customers who use TnI-Ultrat results solely from either the ADVIA Centaur/ ADVIA Centaur XP/ ADVIA Centaur XPT system or the ADVIA Centaur CP system.
Affected products
A. ADVIA Centaur System-Troponin I Ultra (TnI-Ultra) Assay
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
2789602
2790309
Companies
- Manufacturer
-
Siemens Healthcare Diagnostics Inc.
511 Benedict Ave
Tarrytown
New York
UNITED STATES
B. ADVIA Centaur XP system-Troponin I Ultra (TnI-Ultra) Assay
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
02789602
02790309
Companies
- Manufacturer
-
Siemens Healthcare Diagnostics Inc.
511 Benedict Ave
Tarrytown
New York
UNITED STATES
C. ADVIA Centaur CP system-Troponin I Ultra (TnI-Ultra) Assay
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
2789602
2790309
Companies
- Manufacturer
-
Siemens Healthcare Diagnostics Inc.
511 Benedict Ave
Tarrytown
New York
UNITED STATES