Health product recall

Monoclonal Mouse Anti-Pneumocystis Jiroveci, Clone 3F6 and Monoclonal Mouse Ant-Human Leukemia, Hairy Cell Clone DBA.44 (2018-03-23)

Starting date:
March 23, 2018
Posting date:
April 24, 2018
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-66514

Affected products

  1. Monoclonal Mouse Anti-Pneumocystis Jiroveci, Clone 3F6
  2. Monoclonal Mouse Ant-Human Leukemia, Hairy Cell Clone DBA.44

Reason

The primary labels of the affected vials of M0778 and M0880 were mislabeled with an incorrect concentration. For M0778, the concentration was written to be 30 mg/L. The correct concentration is 75 mg/L. For M0880, the concentration was written to be 187 mg/L. The correct concentration is 485 mg/L.

Affected products

  1. Monoclonal Mouse Anti-Pneumocystis Jiroveci, Clone 3F6

Lot or serial number
  • 20010445
Model or catalog number
  • M0778
Companies
Manufacturer
DAKO Denmark A/S
Produktionsvej 42
Glostrup, Copenhagen
2600
DENMARK

B. Monoclonal Mouse Ant-Human Leukemia, Hairy Cell Clone DBA.44

Lot or serial number

20033445
20042272

Model or catalog number

M0880

Companies
Manufacturer
DAKO Denmark A/S
Produktionsvej 42
Glostrup, Copenhagen
2600
DENMARK

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