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HerpeSelect 1 and 2 Immunoblot IgG
- Starting date:
- February 24, 2017
- Posting date:
- March 24, 2017
- 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-62782
Reason
Diasorin Molecular have recently received customer complaints regarding IB0900G Lot# 32574 and 32865 producing strong common ag bands with no bands for glycoprotein G1 and G2. As a consequence, the lack of G1 and G2 bands has led to an increase in equivocal results.
Affected products
HerpeSelect 1 and 2 Immunoblot IgG
Lot or serial number
32574
32865
Model or catalog number
IB0900G
Companies
- Manufacturer
-
Diasorin Molecular LLC (also trading as Focus Diagnostics, Inc.)
11331 Valley View Street
Cypress
90630
California
UNITED STATES