Roche Diagnostics Operations, Inc. Recall 88398
Description: cobas infinity central lab running software version 3.01.03 through 3.02.08, Catalog#: 07154003001
Roche Diagnostics Operations, Inc. Recall 88398 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-2444-2021 |
| Event ID | 88398 |
| Event Description | cobas infinity central lab running software version 3.01.03 through 3.02.08, Catalog#: 07154003001 |
| Product Type | Devices |
| Distribution | US Nationwide distribution |
| Quantity | 2058 licenses worldwide, 79 licenses in US |
| Recall 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. |
| Device Classification | 20210922 |
| Device Code Info | UDI: 04015630936007; All systems running software version 3.01.03 - 3.02.08 |
| Center Classification Date | 20210910 |
| Recall Initiation Date | 20210624 |
| Recalling Firm | Roche Diagnostics Operations, Inc. |
| Initial Notification | Letter |
| Similar To |