CLASS II ONGOING Device recall · Reported 11 May 2022 · FDA Enforcement Report
Advia Centaur Enhanced Estradiol (eE2) 100T recalled
Siemens Healthcare Diagnostics is recalling Advia Centaur Enhanced Estradiol (eE2) 100T - In vitro diagnostic use in the quantitative, distributed nationwide in the US. The recall was initiated on 3 Mar 2022 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1023-2022
- FDA event ID
- 89953
- Recalling firm
- Siemens Healthcare Diagnostics, East Walpole, MA
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 3 Mar 2022
- FDA classified
- 29 Apr 2022
- Reported
- 11 May 2022
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Test Kits & Diagnostics
Timeline
| 3 Mar 2022 | Recall initiated by company | |
| 29 Apr 2022 | Classified by FDA | +57 days |
| 11 May 2022 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Falsely Elevated Results Observed with Plasma Specimens, could lead a clinician to misinterpret patient results
Product as listed by the FDA
ADVIA Centaur Enhanced Estradiol (eE2) 100T - In vitro diagnostic use in the quantitative determination of estradiol SMN: 10490889 All lots
Where it was distributed
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.
Questions about this recall
Why was it recalled?
Falsely Elevated Results Observed with Plasma Specimens, could lead a clinician to misinterpret patient results
Which lots are affected?
All lot numbers UDI: (01)00630414573342(10)08930076(17)20220115 (01)00630414573342(10)10982085(17)20221108 (01)00630414573342(10)19929072(17)20210819 (01)00630414573342(10)20298079(17)20220304 (01)00630414573342(10)48171081(17)20220304 (01)00630414573342(10)53554081(17)20220521 (01)00630414573342(10)70551083(17)20220805 (01)00630414573342(10)76055076(17)20220115
Where was it sold?
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.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
5 other products · FDA event 89953This product is part of a recall event; the main page for the event is Advia Centaur Enhanced Estradiol (eE2) 500T recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Advia Centaur Enhanced Estradiol (eE2) 500T recalled | Siemens Healthcare Diagnostics | Other | Nationwide | |
| CLASS II | Advia Centaur Enhanced Estradiol (eE2) recalled | Siemens Healthcare Diagnostics | Other | Nationwide | |
| CLASS II | Atellica IM Enhanced Estradiol (eE2) recalled | Siemens Healthcare Diagnostics | Other | Nationwide | |
| CLASS II | Atellica IM Enhanced Estradiol (eE2) 500T recalled | Siemens Healthcare Diagnostics | Other | Nationwide | |
| CLASS II | Atellica IM Enhanced Estradiol (eE2) 100T recalled | Siemens Healthcare Diagnostics | Other | Nationwide |
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