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FLEX MONOCLONAL MOUSE ANTI-HUMAN CDX2
- Starting date:
- July 14, 2016
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type III
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public, Healthcare Professionals, Hospitals
- Identification number:
- RA-60534
Affected Products
Reason
A packaging error resulted so the instructions for use (IFU) for Dako Product IR 062 (Flex Monoclonal Mouse Anti-Human CD15) was found in the product instead of the IFU for Flex, Monoclonal Mouse Anti-Human CDX2.
Affected products
FLEX MONOCLONAL MOUSE ANTI-HUMAN CDX2
Lot or serial number
10112879
Model or catalog number
IR80
Companies
- Manufacturer
-
Dako North America, Inc.
6392 via Real
Carpinteria
93013
California
UNITED STATES