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PD-L1 IHC 22C3 PHARMDX
- Starting date:
- November 18, 2016
- Posting date:
- December 5, 2016
- 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-61292
Reason
Complaints have been received concerning the missing information in the instructions for use (IFU). The missing information concerns the drying step before deparaffinization where the IHC (immunohistochemistry) slides must be dried in an oven for 1 hour at a specific temperature.
Affected products
PD-L1 IHC 22C3 PHARMDX
Lot or serial number
10115275B
10115275B
Model or catalog number
SK006
SK006
Companies
- Manufacturer
-
Dako North America, Inc.
6392 Via Real
Carpinteria
93013
California
UNITED STATES