BOND Polymer Refine Detection (2019-11-14)
- Starting date:
- November 14, 2019
- Posting date:
- December 6, 2019
- 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-71808
Last updated: 2019-12-06
Affected Products
BOND Polymer Refine Detection
Reason
Leica Biosystems recently became aware that the affected devices were held out of refrigerated storage longer than specified. The maximum temperature the affected devices reached is unknown and may not be covered by the product stability data held by Leica Biosystems newcastle. It is therefore possible that over the course of its shelf life the product might exhibit suboptimal staining. As a precaution, Leica Biosystems newcastle has decided to voluntarily recall the affected lot.
Affected products
BOND Polymer Refine Detection
Lot or serial number
65549
Model or catalog number
DS9800
Companies
- Manufacturer
-
Leica Biosystems Newcastle Ltd.
Balliol Business Park West, Benton Lane, Newcastle
Benton Lane
NE12 8EW
UNITED KINGDOM