Z-1020-2022Class II

Atellica IM Enhanced Estradiol (eE2) 100T - In vitro diagnostic use in the quantitative determination of...

Name: Z-1020-2022 Atellica IM Enhanced Estradiol (eE2) 100T - In vitro diagnostic use in the quantitative determination of...
Creator: Siemens Healthcare Diagnostics, Inc.
Published: 2022-03-03
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2022-03-03 / Open, Classified

FDA source

Siemens Healthcare Diagnostics, Inc. began a recall of Atellica IM Enhanced Estradiol (eE2) 100T - In vitro diagnostic use in the quantitative determination of estradiol SMN: 10995561 All lots on 2022-03-03. FDA classified it as Class II and gives the reason as "Falsely Elevated Results Observed with Plasma Specimens, could lead a clinician to misinterpret patient results". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-1020-2022
Classification: Class II
Status: Open, Classified
Initiated: 2022-03-03
Posted: 2022-04-29
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: Atellica IM Enhanced Estradiol (eE2) 100T - In vitro diagnostic use in the quantitative determination of estradiol SMN: 10995561 All lots
Product code: CHP Radioimmunoassay, Estradiol
Reason for recall: Falsely Elevated Results Observed with Plasma Specimens, could lead a clinician to misinterpret patient results
FDA root cause: Under Investigation by firm
Action: Siemens issued an Urgent Medical Device Correction AIMC 22-03.A.US and Urgent Field Safety Notice AIMC 22-03.A.OUS on 3/3/22. Letter states reason, health risk and action to take: Customers must discontinue use of plasma specimens for testing with the Atellica IM and ADVIA Centaur eE2 assays until further notice. Customers may continue to use the Atellica IM eE2 and ADVIA Centaur eE2 assays with serum specimens. Please review this letter with your Medical Director. Complete and return the Field Correction Effectiveness Check Form attached to this letter within 30 days. If you have received any complaints of illness or adverse events associated with the products listed in Table 1, immediately contact your local Siemens Healthineers Customer Care Center or your local Siemens Healthineers technical support representative. Please retain this letter with your laboratory records and forward this letter to those who may have received this product. Questions: contact your Siemens Healthineers Customer Care Center or your local Siemens Healthineers technical support representative
Quantity in commerce: 2,044 units
Distribution: Worldwide distribution - US Nationwide and the countries of Austria, Belgium, Brazil, Bulgaria, Burkina, Faso Country AG, Cyprus, Denmark, Egypt, Estonia, Finland, France, French Polynesia, Georgia, Greece, Guadeloupe, India, Ireland, Israel, Italy, Kazakhstan, Latvia, Lithuania, Macedonia, Malta, Morocco, Nepal, Netherlands, Norway, Palestinian Ter, Paraguay, Poland, Portugal, Qatar, Romania, Russian Fed., Slovakia, Spain, Sweden, Switzerland, Turkey, Turkmenistan, U.A.E., Ukraine, United Kingdom, Vatican city.
Product codes and lots: All lot numbers UDI: (01)00630414598857(10)53376082(17)20220521 (01)00630414598857(10)53377082(17)20220521 (01)00630414598857(10)70533084(17)20220804

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1020-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1020-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-05-11	2022-04-29
Z-1021-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-05-11	2022-04-29
Z-1022-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-05-11	2022-04-29
Z-1023-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-05-11	2022-04-29
Z-1024-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-05-11	2022-04-29
Z-1025-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-05-11	2022-04-29

Product code CHP

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)