cobas infinity core — Class II medical device recall Z-1158-2020
Terminated recall by Roche Diagnostics Operations, Inc., reported 2020-02-19, distributed in AK, AL, CA, GA, HI, IA, IL, KY…. Alarm flags that have a "<" symbol in front of them are not displayed on the cobas infinity Validation screen.
| Recall number | Z-1158-2020 |
|---|---|
| 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 | 2020-01-07 |
| Classified | 2020-02-12 |
| Reported by FDA | 2020-02-19 |
| Terminated | 2020-10-15 |
| Distributed | AK, AL, CA, GA, HI, IA, IL, KY, MA, MI, MN, MO, MS, MT, NJ, NY, OR, SC, TN |
| Quantity | 26 accounts |
Product
cobas infinity core, Material No. 7154003001. The device is a calculator/data processing module, for clinical use.
Reason for recall
Alarm flags that have a "<" symbol in front of them are not displayed on the cobas infinity Validation screen. This issue affects only customers that are doing manual validation on the cobas infinity Validation screen.
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-1158-2020. 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.