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Behring Coagulation System (BCS)-Instrument (2015-04-27)
- Starting date:
- April 27, 2015
- Posting date:
- May 21, 2015
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type II
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public, Healthcare Professionals, Hospitals
- Identification number:
- RA-53409
Recalled Products
A. Behring Coagulation System (BCS)-Instrument
Reason
Siemens Healthcare Diagnostics has confirmed erroneously high factor ix results with applications on BCS /BCS XP system at the lower end of the measuring range.
Affected products
A. Behring Coagulation System (BCS)-Instrument
Lot or serial number
All lots.
Model or catalog number
- OVIO03
- OVOB03
Companies
- Manufacturer
-
Siemens Healthcare Diagnostics Products Gmbh
Emil-Von-Behring-Str. 76
Marburg
35041
GERMANY