cobas p 612 Pre-Analytical Instrument calculator/data processing… — Class II medical device recall Z-0106-2017
Terminated recall by Roche Diagnostics Operations, Inc., reported 2016-11-02, distributed nationwide. Roche has received four reports of injury caused by the sharp edge of the center guide rail of an analyzers sa
| Recall number | Z-0106-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Roche Diagnostics Operations, Inc., Indianapolis, IN, United States |
| Recall initiated | 2016-07-15 |
| Classified | 2016-10-25 |
| Reported by FDA | 2016-11-02 |
| Terminated | 2017-06-05 |
| Distributed | Nationwide (US) |
| Quantity | 9,014 in |
Product
cobas p 612 Pre-Analytical Instrument calculator/data processing module, for clinical use Product Usage: The cobas 6000 series is a fully automated, random-access, software-controlled system for immunoassay and photometric analysis intended for qualitative and quantitative in vitro determinations using a wide variety of tests. It is optimized for high throughput workloads in the professional environment using a combination of Ion selective electrodes (ISE), a photometric analysis unit an immunoassay analysis module.
Reason for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0106-2017. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.