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N/T Protein Standards SL
- Starting date:
- October 28, 2016
- Posting date:
- November 15, 2016
- 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-61050
Affected Products
Reason
Siemens Healthcare Diagnostics has confirmed that control values may be found out of range (>+/-15%) for N Antiserum to prealbumin using N/T protein control SL/H. Furthermore, controls may be flagged with a turbidity flag (x-flag). We have no indication that other analytes in N/T protein control SL/H are affected by this issue.
Affected products
N/T Protein Standards SL
Lot or serial number
- 084847
- 084847C
- 084847D
- 084847E
- 084847F
Model or catalog number
- OQIP13
Companies
- Manufacturer
-
Siemens Healthcare Diagnostics Products Gmbh
Emil-Von-Behring-Str. 76
Marburg
35041
GERMANY