This page has been archived on the Web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.
Fibrintimer (2013-11-11)
- Starting date:
- November 11, 2013
- Posting date:
- December 17, 2013
- 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-37203
Recalled products
A. Fibrintimer
Reason
Incorrect standard human plasma (SHP) predilution in the title line of the standard calibration curve table in the application sheets of all endogenous coagulation factors were detected in reference guide versions 3.00, 3.01, 3.02. The stated predilutions do not fit to the recommended dilution set of the last calibration curve point.
Affected products
A. Fibrintimer
Lot or serial number
All lots
Model or catalog number
- OVKF03
Companies
- Manufacturer
-
Siemens Healthcare Diagnostics Products GmbH
Emil-Von-Behring-Str. 76
Marburg
35041
GERMANY