medical Class II Updated 2021-09-22

Roche Diagnostics Operations, Inc. recalls cobas infinity central lab running software version 3.01.03

Recalled Product

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


Hazard / Issue

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.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: UDI: 04015630936007; All systems running software version 3.01.03 - 3.02.08
View official government recall

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