cobas p 612 pre-analytical system — Class II medical device recall Z-1090-2017
Terminated recall by Roche Diagnostics Corporation, reported 2017-02-01, distributed in TX, WA.
| Recall number | Z-1090-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Roche Diagnostics Corporation, Indianapolis, IN, United States |
| Recall initiated | 2016-12-27 |
| Classified | 2017-01-24 |
| Reported by FDA | 2017-02-01 |
| Terminated | 2017-08-04 |
| Distributed | TX, WA |
| Quantity | 5 |
| Serial numbers | 63002816, 63002916, 63004316, 63004416, 63004516 |
Product
cobas p 612 pre-analytical system; Pre-analytical sample handling that includes de-capping, Aliquotting and sorting of samples for analysis.
Reason for recall
Not stated by FDA.
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-1090-2017. 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.