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Recall Observatory FDA recall evidence

Device product

cobas infinity central lab running software version 3.01.03 through 3.02.08, Catalog#: 07154003001

Z-2444-2021

June 24, 2021

Class II

Product summary

Firm
Roche Diagnostics Operations, Inc.
Event
Event 88398
Status
Terminated
Classification
Class II
Quantity
2058 licenses worldwide, 79 licenses in US
Official record key
device-enforcement:Z-2444-2021

Official wording

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.

Code information: UDI: 04015630936007; All systems running software version 3.01.03 - 3.02.08

Distribution pattern: US Nationwide distribution

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.