cobas¿ 4800 system z480 instrument — Class II medical device recall Z-1346-2013
Terminated recall by Roche Molecular Systems, Inc., reported 2013-05-29, distributed nationwide. In rare instances, channel shifted results have been generated with cobas¿ 4800 assays run on v1.1.1 of the co
| Recall number | Z-1346-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Roche Molecular Systems, Inc., Branchburg, NJ, United States |
| Recall initiated | 2013-04-01 |
| Classified | 2013-05-21 |
| Reported by FDA | 2013-05-29 |
| Terminated | 2014-08-07 |
| Distributed | Nationwide (US) |
| Quantity | 425 instruments |
| Serial numbers | 4800 |
Product
cobas¿ 4800 system z480 instrument. Integrates fully automated total nucleic acid isolation directly from secondary sample tubes.
Reason for recall
In rare instances, channel shifted results have been generated with cobas¿ 4800 assays run on v1.1.1 of the cobas¿ 4800 system. Raw data review indicates that, in these cases, all signals are shifted by one channel: channel 1 results report as channel 2, channel 2 results report as channel 3, channel 3 results report as channel 4, and channel 4 results report as channel 1. In the reported
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-1346-2013. 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.