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HemosIL PT-Fibrinogen HS PLUS (2014-11-21)
- Starting date:
- November 21, 2014
- Posting date:
- November 28, 2014
- 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-42669
Recalled Products
HemosIL PT-Fibrinogen HS PLUS
Reason
Some vials of HemosIL PT-Fibrinogen HS PLUS, PN 0008469810, exhibit a yellow/brownish color after reconstitution instead of the typical white to off-white color. These vials were observed to cause prolonged prothrombin (PT) clotting times. If an affected vial is used with a patient sample, a significant shift in INR greater than 10% could occur with the potential to alter medical treatment.
Affected products
HemosIL PT-Fibrinogen HS PLUS
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
0008469810
Companies
- Manufacturer
-
Instrumentation Laboratory Co.
180 Hartwell Road
Bedford
01730-2443
Massachusetts
UNITED STATES