FDA Device recall Z-2444-2021
cobas infinity central lab running software version 3.01.03 through 3.02.08, Catalog#: 07154003001
- FDA Device
- Class II
- terminated
- Published 2021-09-22
On 2021-09-22 the FDA classified a Class II recall of cobas infinity central lab running software version 3.01.03 through 3.02.08, Catalog#: 07154003001 by Roche Diagnostics Operations, citing 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 releas….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2444-2021 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2021-06-24 |
| Published | 2021-09-22 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Roche Diagnostics Operations |
| Distribution | US |
Product
cobas infinity central lab running software version 3.01.03 through 3.02.08, Catalog#: 07154003001
Reason
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.
Identifiers
| code_info | UDI: 04015630936007; All systems running software version 3.01.03 - 3.02.08 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 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-2444-2021%22
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