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Health product recall

Monoclonal Mouse Anti-Human Muts Protein Homolog 2

Starting date:
May 1, 2017
Posting date:
June 5, 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-63466

Reason

The primary labels of the affected vials of M3639 were mislabeled with an incorrect concentration of 180 mg/L, which is ten times higher than the correct concentration of 18 mg/L.

Affected products

Monoclonal Mouse Anti-Human Muts Protein Homolog 2

Lot or serial number

10106449

10109387

10111672

Model or catalog number

M3639

Companies

Manufacturer

Dako North America, Inc.

6392 via Real

Carpinteria

93013

California

UNITED STATES