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N Latex B2 Microglobulin (2014-10-01)
- Starting date:
- October 1, 2014
- Posting date:
- October 10, 2014
- 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-41747
Recalled Products
N Latex B2 Microglobulin
Reason
Siemens Healthcare Diagnostics has received a small number of complaints about calibration failure with N Latex B2 Microglobulin. In rare cases the signal generated at the highest calibration point can exceed the analog-digital converter capacity of an affected BN system. This effect does not allow the establishment of a calibration curve due an invalid calibration point measurement.
Affected products
N Latex B2 Microglobulin
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
OQWU15
Companies
- Manufacturer
-
Siemens Healthcare Diagnostics Products GmbH
Emil-Von-Behring-Str. 76
Marburg
35041
GERMANY