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Monoclonal Mouse Anti-Human Cytokeratin High Molecular Weight
- Starting date:
- June 27, 2017
- Posting date:
- July 18, 2017
- 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-64018
Reason
The primary (vial) labels of the affected vials of M0630 were mislabeled with an incorrect concentration of 11.2 mcg/mL. Additionally, some customers might also have received a certificate of analysis (CoA) stating the same incorrect concentration. The correct concentration is 23.5 mcg/ml.
Affected products
Monoclonal Mouse Anti-Human Cytokeratin High Molecular Weight
Lot or serial number
10115298
10115412
Model or catalog number
M0630
Companies
- Manufacturer
-
Dako North America, Inc.
6392 via Real
Carpinteria
93013
California
UNITED STATES