Food, drugs, devices › Siemens Healthcare Diagnostics, Inc.
Device recall: Atellica IM Enhanced Estradiol (eE2) 100T - In vitro diagnostic use in the quantitative determination of estradiol SMN:
FDA enforcement event 89953 is a device recall by Siemens Healthcare Diagnostics, Inc. of East Walpole, MA, initiated 3 Mar 2022 and classified Class II, with 6 product records.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 88% of the 839 device enforcement events initiated in 2022 carry the same class.
Status: Ongoing. Initiation: voluntary: firm initiated. Siemens Healthcare Diagnostics, Inc. has 333 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Siemens Healthcare Diagnostics, Inc., East Walpole, MA.
Reason for recall
"Falsely Elevated Results Observed with Plasma Specimens, could lead a clinician to misinterpret patient results"
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,…"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-1020-2022 | Atellica IM Enhanced Estradiol (eE2) 100T - In vitro diagnostic use in the quantitative determination of estradiol SMN: 10995561 All lots | 2,044 units | Class II | Ongoing | 11 May 2022 |
| Z-1021-2022 | Atellica IM Enhanced Estradiol (eE2) 500T - In vitro diagnostic use in the quantitative determination of estradiol SMN: 10995562 All lots | 374 units | Class II | Ongoing | 11 May 2022 |
| Z-1022-2022 | Atellica IM Enhanced Estradiol (eE2) (REF) 500T - In vitro diagnostic use in the quantitative determination of estradiol SMN: 11206250 All lots | 230 units | Class II | Ongoing | 11 May 2022 |
| Z-1023-2022 | ADVIA Centaur Enhanced Estradiol (eE2) 100T - In vitro diagnostic use in the quantitative determination of estradiol SMN: 10490889 All lots | 2,315 units | Class II | Ongoing | 11 May 2022 |
| Z-1024-2022 | ADVIA Centaur Enhanced Estradiol (eE2) 500T - In vitro diagnostic use in the quantitative determination of estradiol SMN: 10491445 All lots | 952 units | Class II | Ongoing | 11 May 2022 |
| Z-1025-2022 | ADVIA Centaur Enhanced Estradiol (eE2) (REF) 500T - In vitro diagnostic use in the quantitative detection of estradiol SMN: 10697757 All lots | 88 units | Class II | Ongoing | 11 May 2022 |
Context
Other enforcement events for Siemens Healthcare Diagnostics, Inc.
All 333 events for Siemens Healthcare Diagnostics, Inc.
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "Falsely Elevated Results Observed with Plasma Specimens, could lead a clinician to misinterpret patient results"
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "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,…"
Is the recall still ongoing?
FDA lists the status as Ongoing. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.