FDAJune 24, 2021device

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

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

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.

What to do

FDA enforcement status: Terminated

Brands named

roche diagnostics operationsrocheroche diagnostics

UPCs

0401563093600707154003001

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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