Bulk Loader Module for cobas p 512/612 Pre-analytical sample handling… — Class II medical device recall Z-0297-2016
Terminated recall by Roche Diagnostics Operations, Inc., reported 2015-11-25, distributed in TX. Possible for sample tubes in the loader to be opened and contaminate the system as well as adjacent samples du
| Recall number | Z-0297-2016 |
|---|---|
| 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 | 2015-09-22 |
| Classified | 2015-11-18 |
| Reported by FDA | 2015-11-25 |
| Terminated | 2016-02-03 |
| Distributed | TX |
| Quantity | 1 |
| Model numbers | 07135645001 |
Product
Bulk Loader Module for cobas p 512/612 Pre-analytical sample handling that includes de-capping, aliquoting and sorting of samples for analysis. In vitro diagnostic machine component.
Reason for recall
Possible for sample tubes in the loader to be opened and contaminate the system as well as adjacent samples during processing.
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-0297-2016. 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.