Health product recall

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

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

A. ADVIA Centaur CP System - CA 125 II Assay

Lot or serial number

More than 100 numbers, contact manufacturer.

Model or catalog number

01678114
09427226
 

Companies
Manufacturer
Siemens Healthcare Diagnostics Inc.
511 Benedict Ave
Tarrytown
10591
UNITED STATES

B. ADVIA Centaur System - CA 125 II ASSAY

Lot or serial number

More than 100 numbers, contact manufacturer.

Model or catalog number

01678114
09427226

Companies
Manufacturer
Siemens Healthcare Diagnostics Inc.
511 Benedict Ave
Tarrytown
10591
UNITED STATES