Health product recall

Atellica

Last updated

Summary

Product
Atellica
Issue
Medical devices - Inaccurate test or measurement results
What to do

Contact the manufacturer if you require additional information.

Affected products

Affected Products

Lot or Serial Number

Model or catalog number

Atellica Im Enhanced Estradiol (Ee2)

All lots.

10995562, 10995561

Advia Centaur System - Enhanced Estradiol (Ee2) Assay

All lots.

10490889, 10491445

Advia Centaur Cp System - Enhanced Estradiol (Ee2) Assay

All lots.

10490889, 10491445

Issue

Siemens Healthcare Diagnostics Inc. has confirmed customer observations of falsely elevated results when using plasma specimens across the entire analytical measuring range (AMR) with the Atellica IM enhanced estradiol (EE2) assay. Results demonstrate that plasma specimens are not meeting claims as defined in the instructions for use (IFU). limited data is available at this time as the investigation for this issue is on-going.

Recall start date: Mar 9, 2022

 

Additional information

Details
Original published date: 2022-03-17
Alert / recall type
Health product recall
Category
Health product - Medical device - Cardiovascular
Health product - Medical device - Chemistry
Companies

Siemens Healthcare Diagnostics Inc.

511 Benedict Ave, Tarrytown, New York

United States, 10591

Published by
Health Canada
Audience
General public
Health professionals
Hospitals
Recall class
Type II
Identification number
RA-63995