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MONOCLONAL MOUSE ANTI-HUMAN CDX2 (2017-10-27)
- Starting date:
- October 27, 2017
- Posting date:
- November 10, 2017
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type II
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- Healthcare Professionals, General Public, Hospitals
- Identification number:
- RA-65076
Affected products
MONOCLONAL MOUSE ANTI-HUMAN CDX2
Reason
The Certificate of Analysis (COA) and the primary labels of the affected vials of m3636 were mislabeled with an incorrect protein concentration value of 292.7 mg/l, which is sixteen times higher than the correct concentration of 18.3 mg/l.
Affected products
MONOCLONAL MOUSE ANTI-HUMAN CDX2
Lot or serial number
M363601-2 lot 10117361
M363601-2 lot 10121392
M363629-2 lot 10117138
M363629-2 lot 10121395
Model or catalog number
M3636
Companies
- Manufacturer
-
Dako North America, Inc.
6392 via Real
Carpinteria
93013
California
UNITED STATES