N Latex CDT (Carbohydrate-Deficient Transferrin) Kit (2018-05-24)

Starting date:

May 24, 2018

Posting date:

June 6, 2018

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-66982

• 
  Reason
• 
  Affected products

Affected products

N Latex CDT (Carbohydrate-Deficient Transferrin) Kit

Reason

Siemens Healthcare Diagnostics has observed a negative bias of approximately 15% for the Carbohydrate-Deficient Transferrin (CDT) measurement when using the affected N latex CDT lots in comparison to the HPLC method.

Affected products