cobas p 512 pre-analytical system Pre-analytical sample handling that… — Class II medical device recall Z-1233-2016
Terminated recall by Roche Diagnostics Operations, Inc., reported 2016-03-30, distributed in AZ, GA, MI, OH, PR, TN, TX, WA. Due to a false triggering or detection of the lifting gripper READY signal, sample tubes are not correctly pla
| Recall number | Z-1233-2016 |
|---|---|
| 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 | 2016-02-23 |
| Classified | 2016-03-23 |
| Reported by FDA | 2016-03-30 |
| Terminated | 2018-01-11 |
| Distributed | AZ, GA, MI, OH, PR, TN, TX, WA |
| Quantity | 35 units |
| Model numbers | 05083435001, 06268854001 |
Product
cobas p 512 pre-analytical system Pre-analytical sample handling that includes de-capping, aliquoting and sorting of samples for analysis.
Reason for recall
Due to a false triggering or detection of the lifting gripper READY signal, sample tubes are not correctly placed back in the Rack Tube Transport (RTT) after the decapping process. Therefore, open sample tubes can be dropped in the cobas p 512, spilling the sample material.
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-1233-2016. 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.