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Testosterone Gen II Test Kit (2014-01-27)
- Starting date:
- January 27, 2014
- Posting date:
- March 18, 2014
- 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-38321
Recalled Products
Testosterone Gen II Test Kit
Reason
The reason for the recall is related to a situation where the manufacturer has identified during an internal investigation, that a change was required in the claims of the Testosterone Assay.
Affected products
Testosterone Gen II Test Kit
Lot or serial number
All lots
Model or catalog number
05200067190
Companies
- Manufacturer
-
Roche Diagnostics GmbH
Sandhofer Strasse 116
Mannheim
68305
GERMANY