ADVIA Centaur and ADVIA Centaur CP System - CA 125 II Assay (2018-02-23)

Starting date:

February 23, 2018

Posting date:

March 19, 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-66186

• 
  Reason
• 
  Affected products

Affected products

A. ADVIA Centaur CP System - CA 125 II Assay

B. ADVIA Centaur System - CA 125 II ASSAY

Reason

Siemens is issuing a communication to advise that some patient samples exhibit sample specific dilution over-recovery outside of the representative dilution recovery data provided in the ADVIA Centaur CA 125 II assay instruction for use. Investigations performed by Siemens healthcare diagnostics demonstrated dilution recoveries up to 140% with certain patient samples. Studies indicate the dilution over-recovery is patient sample specific.

The ADVIA Centaur CA 125 II assay instruction for use will be updated to include a statement referring to the potential for sample specific non-linear dilution. The performance of the ADVIA Centaur CA 125 II assay has not changed.

Affected products