Product Safety Recalls

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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

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberZ-2444-2021
Event ID88398
Event Descriptioncobas infinity central lab running software version 3.01.03 through 3.02.08, Catalog#: 07154003001
Product TypeDevices
DistributionUS Nationwide distribution
Quantity2058 licenses worldwide, 79 licenses in US
Recall ReasonUnder 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 Classification20210922
Device Code InfoUDI: 04015630936007; All systems running software version 3.01.03 - 3.02.08
Center Classification Date20210910
Recall Initiation Date20210624
Recalling FirmRoche Diagnostics Operations, Inc.
Initial Notification Letter
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