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ADVIA CENTAUR CP SYSTEM THYROXINE T4 ASSAY (2015-11-23)
- Starting date:
- November 23, 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-56290
Affected Products
- ADVIA CENTAUR CP SYSTEM - THYROXINE (T4) ASSAY
- ADVIA CENTAUR SYSTEM - T4 ASSAY
Reason
Siemens Healthcare Diagnostics is currently investigating confirmed reports of calibration slope failures on the ADVIA Centaur Systems T4 Reagent Lots listed in section 64(a). A failed calibration slope will result in an invalid calibration status which will prevent T4 patient results from being generated. If the calibration slope passes and controls are within laboratory limits, patient results are considered valid and may be reported.
Affected products
A. ADVIA CENTAUR CP SYSTEM - THYROXINE (T4) ASSAY
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
- 110735
- 110736
Companies
- Manufacturer
-
Siemens Healthcare Diagnostics Inc.
511 Benedict Ave
Tarrytown
10591
New York
UNITED STATES
B. ADVIA CENTAUR SYSTEM - T4 ASSAY
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
- 110735
- 110736
Companies
- Manufacturer
-
Siemens Healthcare Diagnostics Inc.
511 Benedict Ave
Tarrytown
10591
New York
UNITED STATES