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BC-THROMBIN REAGENT (2017-10-12)
- Starting date:
- October 12, 2017
- Posting date:
- October 27, 2017
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type II
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- Healthcare Professionals, Hospitals, General Public
- Identification number:
- RA-64962
Affected products
BC-THROMBIN REAGENT
Reason
The BC Thrombin Reagent Kit lots 46751 (contains Thrombin Reagent lot 517468) and Kit lot 47184 (contains Thrombin Reagent lot 517469) produce unexpected prolonged thrombin time results for expected normal samples, and may recover above the upper limit of normal which is 21 sec as stated within the IFU (instruction for use) and the BCS/ BCS XP System application sheets.
Affected products
BC-THROMBIN REAGENT
Lot or serial number
- 46751
- 47184
Model or catalog number
OWNA11
Companies
- Manufacturer
-
Siemens Healthcare Diagnostics Products Gmbh
Emil-Von-Behring-Str. 76
Marburg
35041
GERMANY