This page has been archived on the Web
Information identified as archived is provided for reference, research or recordkeeping purposes. It is not subject to the Government of Canada Web Standards and has not been altered or updated since it was archived. Please contact us to request a format other than those available.
Behring Coagulation System (BCS) Instrument (2015-05-11)
- Starting date:
- May 11, 2015
- Posting date:
- June 3, 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-53647
Recalled Products
A. Behring Coagulation System (BCS) Instrument
Reason
Siemens has confirmed that for Multifibren U (catalog numbers OWZG19, OWZG23), Fibrinogen Calibrator Kit (catalog number OQVK11) and Control Plasma N (catalog numbers ORKE41, ORKE45), users may receive a number of error messages when measuring a calibration curve on the Behring coagulation system (BCS) and BCS XP instruments.
Affected products
A. Behring Coagulation System (BCS) Instrument
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
- OVIO03
- OVOB03
Companies
- Manufacturer
-
Siemens Healthcare Diagnostics Products Gmbh
Emil-Von-Behring-Str. 76
Marburg
35041
GERMANY