cobas infinity central lab running software version 3 — Class II medical device recall Z-2444-2021
Terminated recall by Roche Diagnostics Operations, Inc., reported 2021-09-22, distributed nationwide. Under specific circumstances created by the user, the cobas e flow test results could be replaced by an automa
| Recall number | Z-2444-2021 |
|---|---|
| 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 | 2021-06-24 |
| Classified | 2021-09-10 |
| Reported by FDA | 2021-09-22 |
| Terminated | 2023-07-21 |
| Distributed | Nationwide (US) |
| UPC / GTIN / UDI-DI | 04015630936007 |
| Model numbers | 07154003001 |
Product
cobas infinity central lab running software version 3.01.03 through 3.02.08, Catalog#: 07154003001
Reason for recall
Under specific circumstances created by the user, the cobas e flow test results could be replaced by an automatic result sent to the lab LIS. This automatic result could be released and interpreted by your Laboratory Information System (LIS) as a false positive or negative result. It should be noted that the "correct" result would still be available on the instrument.
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-2444-2021. 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.