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INFORM HER2 DNA Probe (2015-02-02)
- Starting date:
- February 2, 2015
- Posting date:
- March 6, 2015
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type III
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- Hospitals, General Public, Healthcare Professionals
- Identification number:
- RA-43833
Recalled products
- INFORM HER2 DNA Probe
Reason
The method sheet (Version E) of the INFORM HER2 DNA probe was missing from the Ventana website under the Canada section, as indicated on the reagent kit.
Affected products
A. INFORM HER2 DNA Probe
Lot or serial number
All lots
Model or catalog number
- 780-4332
Companies
- Manufacturer
-
Roche Diagnostics Gmbh
Sandhoferstrasse 116
Mannheim