Recall archive / FDA device enforcement
ADVIA Centaur Enhanced Estradiol (eE2) 100T - In vitro diagnostic use in the quantitative determination of estradiol ... — FDA record Z-1023-2022
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Mar 3, 2022. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- ADVIA Centaur Enhanced Estradiol (eE2) 100T - In vitro diagnostic use in the quantitative determination of estradiol SMN: 10490889 All lots
- Reason
- Falsely Elevated Results Observed with Plasma Specimens, could lead a clinician to misinterpret patient results
- Classification
- Class II
- Recalling firm
- Siemens Healthcare Diagnostics, Inc.
- Quantity
- 2,315 units
- Agency-reported status
- Ongoing
- Source record identifier
- Z-1023-2022
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | 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 |
Match all identifying details in the current notice. A brand name alone is not enough.
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.
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
- Alaska
- Alabama
- Arkansas
- Arizona
- California
- Colorado
- Connecticut
- Delaware
- Florida
- Georgia
- Hawaii
- Iowa
- Idaho
- Illinois
- Indiana
- Kansas
- Kentucky
- Louisiana
- Massachusetts
- Maryland
- Maine
- Michigan
- Minnesota
- Missouri
- Mississippi
- Montana
- North Carolina
- North Dakota
- Nebraska
- New Hampshire
- New Jersey
- New Mexico
- Nevada
- New York
- Ohio
- Oklahoma
- Oregon
- Pennsylvania
- Rhode Island
- South Carolina
- South Dakota
- Tennessee
- Texas
- Utah
- Virginia
- Vermont
- Washington
- Wisconsin
- West Virginia
- Wyoming
Dates in the source
- Report date
- May 11, 2022
- Recall initiation date
- Mar 3, 2022
- Center classification date
- Apr 29, 2022
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.