FDA Device recall Z-0094-2017
Roche/Hitachi MODULAR Analytics Combination Systems Modular D/P: Clinical Chemistry Analyzer, Chemistry (Photometric, Discrete) for clinica…
- FDA Device
- Class II
- terminated
- Published 2016-11-02
On 2016-11-02 the FDA classified a Class II recall of Roche/Hitachi MODULAR Analytics Combination Systems Modular D/P: Clinical Chemistry Analyzer, Chemistry (Photometric, Discrete) for clinica… by Roche Diagnostics Operations, citing roche has received four reports of injury caused by the sharp edge of the center guide rail of an analyzers sample rack tray. The cleaning procedure for the sample rack tray has….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0094-2017 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-07-15 |
| Published | 2016-11-02 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Roche Diagnostics Operations |
| Distribution | US |
Product
Roche/Hitachi MODULAR Analytics Combination Systems Modular D/P: Clinical Chemistry Analyzer, Chemistry (Photometric, Discrete) for clinical use. Modular E170: Immunoassay Analyzer Product Usage: The Roche COBAS INTEGRA 800/800 CTS Analyzer is fully automated system for clinical chemistry analysis intended for the in vitro quantitative/qualitative determination of analytes in body fluids.
Reason
Roche has received four reports of injury caused by the sharp edge of the center guide rail of an analyzers sample rack tray. The cleaning procedure for the sample rack tray has been revised to clarify the cleaning process.
Identifiers
| code_info | Not applicable |
|---|
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-0094-2017%22
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