FDA Device recall Z-0461-2021
cobas infinity central lab/cobas infinity core license-The cobas infinity IT solutions application is intended to be used for the configura…
- FDA Device
- Class II
- terminated
- Published 2020-11-25
On 2020-11-25 the FDA classified a Class II recall of cobas infinity central lab/cobas infinity core license-The cobas infinity IT solutions application is intended to be used for the configura… by Roche Diagnostics Operations, citing potential Incorrect Validation of Results Due to an Erroneous QC Status When Using Status Expiration Control Rule.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0461-2021 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2020-10-09 |
| Published | 2020-11-25 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Roche Diagnostics Operations |
| Distribution | US |
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
Potential Incorrect Validation of Results Due to an Erroneous QC Status When Using Status Expiration Control Rule
Identifiers
| code_info | Software versions from cobas infinity version 3.00.00 onwards Serial Numbers: 82014 82229 82028 82227 82066 819…Software versions from cobas infinity version 3.00.00 onwards Serial Numbers: 82014 82229 82028 82227 82066 81967 81946 82121 82027 82194 82120 81528 82231 81958 82246 81983 82118 82165 81886 82082 82256 82257 81781 82331 82304 82087 82276 81465 81959 82235 82180 82181 82236 81945 82275 81662 82065 82253 81817 82000 |
|---|
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-0461-2021%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.