FDA Device recall Z-1253-2022
Atellica IM 1600 Analyzer - automated, immunoassay analyzer designed to perform in vitro diagnostic tests on clinical specimens Siemens Mat…
- FDA Device
- Class II
- ongoing
- Published 2022-06-15
On 2022-06-15 the FDA classified a Class II recall of Atellica IM 1600 Analyzer - automated, immunoassay analyzer designed to perform in vitro diagnostic tests on clinical specimens Siemens Mat… by Siemens Healthcare Diagnostics, citing lots incompatible with Test Definition (TDef) Version 1.4, potentially lead to the generation of erroneous total T3 results.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1253-2022 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2022-04-13 |
| Published | 2022-06-15 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Siemens Healthcare Diagnostics |
| Distribution | US |
Product
Atellica IM 1600 Analyzer - automated, immunoassay analyzer designed to perform in vitro diagnostic tests on clinical specimens Siemens Material Number (SMN): 11066000
Reason
Lots incompatible with Test Definition (TDef) Version 1.4, potentially lead to the generation of erroneous total T3 results
Identifiers
| code_info | UDI: 00630414002026 All lots |
|---|
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-1253-2022%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.