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Her2 Fish System - 30 Test (2014-07-23)
- Starting date:
- July 23, 2014
- Posting date:
- August 15, 2014
- 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-41035
Recalled products
- Her2 Fish System - 30 Test
Reason
Leica Biosystems recently became aware that TA9217 lot 26806 contains mislabelled bond open containers. The containers display a Research Use Only (RUO) label and the inclusion of these containers as part of the Leica Her2 Fish System will prevent the user to be able to run the test. The bond instrument data management system (DMS) software will not allow the RUO-labelled bond open container to be used as part of the system.
Affected products
A. Her2 Fish System - 30 Test
Lot or serial number
- 26806
Model or catalog number
- TA9217
Companies
- Manufacturer
-
Leica Biosystems Newcastle Ltd.
Balliol Business Park West, Benton Lane,
Newcastle upon Tyne, Tyne and Wear,
NE12 8EW
UNITED KINGDOM