Unicel Dxi 600 and 800 Access Immunoassay Br Monitors (2017-04-14)

Starting date:

April 14, 2017

Posting date:

May 16, 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-63296

• 
  Reason
• 
  Affected products

Affected Products

A. Unicel Dxi 600 Access Immunoassay System - Br Monitor (Ca 15-3) Assay

B. Access Immunoassay System - Br Monitor (Ca 15-3) Assay

C. Unicel Dxi 800 Access Immunoassay System - Br Monitor (Ca 15-3) Assay

Reason

Following biases observed in the results of the French national quality controls, Beckman Coulter has been informed that a study completed by the French competent authority Agence Nationale de Securite du Medicament et des Produits de Sante (ANSM) showed diagnosed cancer patients in non-remission of their metastatic disease, may have results below the upper reference limit (URL) of 31.3 u/ml as stated in the access BR monitor instructions for use (IFU).

Affected products