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

• 
  Reason
• 
  Affected products

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