FDA Device recall Z-0193-2019
Atellica IM 1600 Analyzer (SMN 11066000)
- FDA Device
- Class II
- terminated
- Published 2018-10-24
On 2018-10-24 the FDA classified a Class II recall of Atellica IM 1600 Analyzer (SMN 11066000) by Siemens Healthcare Diagnostics, citing atellica Solution system software (SW) version 1.13 and lower, five (5) behavioral issues were identified: 1. Reagent Lock may not work as intended with Primary Reagent ReadyPacks….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0193-2019 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-06-29 |
| Published | 2018-10-24 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Siemens Healthcare Diagnostics |
| Distribution | US |
Product
Atellica IM 1600 Analyzer (SMN 11066000). The Atellica" Solution is a multi-component system for in vitro diagnostic testing of clinical specimens.
Reason
Atellica Solution system software (SW) version 1.13 and lower, five (5) behavioral issues were identified: 1. Reagent Lock may not work as intended with Primary Reagent ReadyPacks¿ and Ancillary Packs when more than one (1) lot of specific Reagent kits are loaded on the analyzer at the same time. 2. Sample barcodes may be incorrectly read 3. The Atellica IM 1300 Analyzer and Atellica IM 1600 Analyzer may not run CEA dilutions at 50x and 100x. The Analyzer may post a Sample Integrity Error when 50x or 100x dilutions are ordered for Carcinoembryonic Antigen (CEA). Dilution factors lower than 50x and neat samples are not affected by this behavior. 4. The Atellica CH 930 Analyzer may continue to display the default reporting units after the reporting units have been changed. 5. The Atellica CH 930 Analyzer may not display results for sample if certain assays are configured to auto-dilute results above or below the assay measuring interval.
Identifiers
| code_info | Software (SW) version 1.13 and lower |
|---|
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-0193-2019%22
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