Atellica System
Brand(s)
Summary
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
Siemens Healthcare Diagnostics Inc.
511 Benedict Ave, Tarrytown, New York
United States, 10591
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