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UREA NITROGEN (UN) ASSAYS (2015-08-07)
- Starting date:
- August 7, 2015
- Posting date:
- August 24, 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-54772
Affected Products
A. ADVIA CHEMISTRY SYSTEM - UREA NITROGEN (UN) ASSAY
B. ADVIA CHEMISTRY SYSTEM - UREA NITROGEN CONCENTRAT
Reason
An increased incidence of calibration failures. Results cannot be generated by the system when calibration fails.
Affected products
A. ADVIA CHEMISTRY SYSTEM - UREA NITROGEN (UN) ASSAY
Lot or serial number
321973
333872
348126
Model or catalog number
03040257
Companies
- Manufacturer
-
Siemens Healthcare Diagnostics Inc.
511 Benedict Ave
Tarrytown
New York
UNITED STATES
B. ADVIA CHEMISTRY SYSTEM - UREA NITROGEN CONCENTRAT
Lot or serial number
321967
332365
Model or catalog number
06860558
Companies
- Manufacturer
-
Siemens Healthcare Diagnostics Inc.
511 Benedict Ave
Tarrytown
New York
UNITED STATES