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 |
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