FDA Device recall Z-1020-2022
Atellica IM Enhanced Estradiol (eE2) 100T - In vitro diagnostic use in the quantitative determination of estradiol SMN: 10995561 All lots
- FDA Device
- Class II
- ongoing
- Published 2022-05-11
On 2022-05-11 the FDA classified a Class II recall of Atellica IM Enhanced Estradiol (eE2) 100T - In vitro diagnostic use in the quantitative determination of estradiol SMN: 10995561 All lots 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-1020-2022 |
| 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
Atellica IM Enhanced Estradiol (eE2) 100T - In vitro diagnostic use in the quantitative determination of estradiol SMN: 10995561 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)00630414598857(10)53376082(17)20220521 (01)00630414598857(10)53377082(17)20220521 (01)00630414598857(10)70533084(17)20220804 |
|---|
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-1020-2022%22
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