FDA Device recall Z-1586-2018
Atelia IM 1300 Analyzer for in vitro diagnostic testing of clinical specimens
- FDA Device
- Class II
- terminated
- Published 2018-05-09
On 2018-05-09 the FDA classified a Class II recall of Atelia IM 1300 Analyzer for in vitro diagnostic testing of clinical specimens by Siemens Healthcare Diagnostics, citing when more than one immunoassay analyzer is connected to a single solution system, reporting and conversion factors may not be applied to all analyzers.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1586-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-02-26 |
| Published | 2018-05-09 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Siemens Healthcare Diagnostics |
| Distribution | FL |
Product
Atelia IM 1300 Analyzer for in vitro diagnostic testing of clinical specimens.
Reason
When more than one immunoassay analyzer is connected to a single solution system, reporting and conversion factors may not be applied to all analyzers
Identifiers
| code_info | UDI 00630414007960 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1586-2018%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.