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LEICA BOND POLYMER REFINE RED DETECTION (2015-11-16)
- Starting date:
- November 16, 2015
- Posting date:
- December 24, 2015
- 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-56470
Recalled Products
A. LEICA BOND POLYMER REFINE RED DETECTION DS9390
B. LEICA BOND POLYMER REFINE RED DETECTION
Reason
Leica Biosystems recently became aware that some detection kits may have been subject to a manufacturing error which could result in inadequate staining. If the product is used according to the instructions for use with the adequate controls, the end user would be able to identify the test has not stained correctly.
Affected products
A. LEICA BOND POLYMER REFINE RED DETECTION DS9390
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
DS9390
Companies
- Manufacturer
-
Leica Biosystems Newcastle Ltd.
Balliol Business Park West
Benton Lane
UNITED KINGDOM
B. LEICA BOND POLYMER REFINE RED DETECTION
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
DS9390
Companies
- Manufacturer
-
Leica Biosystems Newcastle Ltd.
Balliol Business Park West
Benton Lane
UNITED KINGDOM