Creatine kinase-MB (CK-MB) (2018-08-05)

Starting date:

August 5, 2018

Posting date:

January 11, 2019

Type of communication:

Medical Device Recall

Subcategory:

Medical Device

Hazard classification:

Type III

Source of recall:

Health Canada

Issue:

Medical Devices

Audience:

General Public, Healthcare Professionals, Hospitals

Identification number:

RA-68732

• 
  Reason
• 
  Affected products

Affected products

Creatine kinase-MB (CK-MB)

Reason

Following internal investigation of customer complaints, the manufacturer confirmed that an increased absolute absorbance for both calibration standards and reduced control recoveries could occur for the product Creatine Kinase-MB (#05168562190) lot # 31195601 used on cobas c 701/702 module.

Affected products