This page has been archived on the Web
Information identified as archived is provided for reference, research or recordkeeping purposes. It is not subject to the Government of Canada Web Standards and has not been altered or updated since it was archived. Please contact us to request a format other than those available.
Leica RTU-TDT-339, 7mL
- Starting date:
- November 2, 2012
- Posting date:
- December 24, 2012
- 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-25861
Recalled Products
- Leica RTU-TDT-339, 7mL
Reason
The recall was intiated as a result of findings that the product may not retain stability through out it's entire 36 month shelf life. The investigation has shown that there is a link between the age of product and the staining intensity and it was found the labelled 36 month shelf life was not appropriate.
Affected products
A. Leica RTU-TDT-339, 7mL
Lot or serial number
6001845, 6009645, 804804, 804805, 804806, 804809, 804810, 804812
Model or catalog number
RTU-TDT-339
Companies
- Manufacturer
- Leica Biosystems Newcastle Ltd.