FDA Device recall Z-1025-2022
ADVIA Centaur Enhanced Estradiol (eE2) (REF) 500T - In vitro diagnostic use in the quantitative detection of estradiol SMN: 10697757 All lo…
- FDA Device
- Class II
- ongoing
- Published 2022-05-11
On 2022-05-11 the FDA classified a Class II recall of ADVIA Centaur Enhanced Estradiol (eE2) (REF) 500T - In vitro diagnostic use in the quantitative detection of estradiol SMN: 10697757 All lo… by Siemens Healthcare Diagnostics, citing falsely Elevated Results Observed with Plasma Specimens, could lead a clinician to misinterpret patient results.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1025-2022 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2022-03-03 |
| Published | 2022-05-11 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Siemens Healthcare Diagnostics |
| Distribution | US |
Product
ADVIA Centaur Enhanced Estradiol (eE2) (REF) 500T - In vitro diagnostic use in the quantitative detection of estradiol SMN: 10697757 All lots
Reason
Falsely Elevated Results Observed with Plasma Specimens, could lead a clinician to misinterpret patient results
Identifiers
| code_info | All lot numbers UDI: (01)00630414591056(10)13852076(17)20220115 (01)00630414591056(10)46894074(17)20211028 (01)00630414591056(10)89042083(17)20220805 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1025-2022%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.