cobas 6800/8800 system Hepatitis Viral B DNA Detection Product Usage:… — Class II medical device recall Z-0110-2017
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 s
| Recall number | Z-0110-2017 |
|---|---|
| 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 6800/8800 system Hepatitis Viral B DNA Detection Product Usage: The cobas p512 pre-analytical system is a computer controlled fully automatic system for sorting of open and closed barcoded and centrifuged sample tubes. It includes modules for registration and decapping of sample tubes, liquid level detection (optional) and sample quality detection (optional), as well as recapping of sample tubes (optional).
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-0110-2017. 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.