HemosIL von Willebrand Factor Antigen (2019-10-15)
- Starting date:
- October 15, 2019
- Posting date:
- November 1, 2019
- 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-71483
Last updated: 2019-11-01
Affected Products
HemosIL von Willebrand Factor Antigen
Reason
Recent internal testing identified current lots of HemosIL von Willebrand Factor Antigen (Part No. 0020002300) are not meeting their labeled claim of no interference for Rheumatoid Factor (RF) interference claim up to 750 IU/ML.
Affected products
HemosIL von Willebrand Factor Antigen
Lot or serial number
- B30670
- B30993
- B31413
- B31699
- B32142
Model or catalog number
20002300
Companies
- Manufacturer
-
Instrumentation Laboratory Co.
180 Hartwell Road
Bedford
01730-2443
Massachusetts
UNITED STATES