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N/T Protein Controls and Standards (2017-05-31)
- Starting date:
- May 31, 2017
- Posting date:
- July 6, 2017
- 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-63800
Affected Products
A. N/T Protein Controls Sl
B. N/T Protein Standards Sl
Reason
Siemens Healthineers has confirmed a negative bias of approximately -20% for results obtained with n antiserum to human ceruloplasmin when calibrating ceruloplasmin with affected N/T protein standard lots. N/T protein controls SL for ceruloplasmin are similarly biased.
Affected products
A. N/T Protein Controls Sl
Lot or serial number
More than 10 numbers, contact manufacturer
Model or catalog number
OQIM13
Companies
- Manufacturer
-
Siemens Healthcare Diagnostics Products Gmbh
Emil-Von-Behring-Str. 76
Marburg
35041
GERMANY
B. N/T Protein Standards Sl
Lot or serial number
More than 10 numbers, contact manufacturer
Model or catalog number
OQIN13
OQIO13
OQIP13
Companies
- Manufacturer
-
Siemens Healthcare Diagnostics Products Gmbh
Emil-Von-Behring-Str. 76
Marburg
35041
GERMANY