FDA Device recall Z-1158-2020
cobas infinity core, Material No. 7154003001
- FDA Device
- Class II
- terminated
- Published 2020-02-19
On 2020-02-19 the FDA classified a Class II recall of cobas infinity core, Material No. 7154003001 by Roche Diagnostics Operations, citing 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 o….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1158-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2020-01-07 |
| Published | 2020-02-19 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Roche Diagnostics Operations |
| Distribution | AK, AL, CA, GA, HI, IA, IL, KY, MA, MI, MN, MO, MS, MT, NJ, NY, OR, SC, TN |
Product
cobas infinity core, Material No. 7154003001. The device is a calculator/data processing module, for clinical use.
Reason
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.
Identifiers
| code_info | All cobas infinity laboratory solution software versions are affected. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
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All Roche Diagnostics Operations recalls
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1158-2020%22
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