cobas infinity central lab/cobas infinity core license-The cobas… — Class II medical device recall Z-0461-2021
Terminated recall by Roche Diagnostics Operations, Inc., reported 2020-11-25, distributed nationwide. Potential Incorrect Validation of Results Due to an Erroneous QC Status When Using Status Expiration Control R
| Recall number | Z-0461-2021 |
|---|---|
| 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 | 2020-10-09 |
| Classified | 2020-11-17 |
| Reported by FDA | 2020-11-25 |
| Terminated | 2023-06-09 |
| Distributed | Nationwide (US) |
| Quantity | 40 licenses |
| Serial numbers | 81465, 81528, 81662, 81781, 81817, 81886, 81945, 81946, 81958, 81959, 81967, 81983, 82000, 82014, 82027, 82028, 82065, 82066, 82082, 82087, 82118, 82120, 82121, 82165, 82180 and 15 more |
| Model numbers | 07154003001 |
Product
cobas infinity central lab/cobas infinity core license-The cobas infinity IT solutions application is intended to be used for the configuration and connectivity management of instruments and software systems Catalog Number: 07154003001
Reason for recall
Potential Incorrect Validation of Results Due to an Erroneous QC Status When Using Status Expiration Control Rule
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-0461-2021. 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.