cobas infinity central lab running software version 3.01.03 through 3.02.08, Catalog#: 07154003001
Check against the official notice below — it lists the full affected range.
Roche Diagnostics Operations, Inc. is recalling cobas infinity central lab systems running software versions 3.01.03 through 3.02.08. Under specific user-created circumstances, the system could replace correct cobas e flow test results with an automatic result that gets sent to the laboratory information system (LIS). This automatic result could be released and misinterpreted by the LIS as a false positive or negative result, though the correct result would remain available on the instrument itself. The recall affects 2,058 licenses worldwide, including 79 licenses in the United States.
The recall impacts all systems running the affected software versions. The source document does not specify a remedy or corrective action for affected consumers.
Written by software from the official notice below. Not reviewed by a lawyer.
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.
Reason for recall: 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. Distribution: US Nationwide distribution Quantity: 2058 licenses worldwide, 79 licenses in US Lot/code info: UDI: 04015630936007; All systems running software version 3.01.03 - 3.02.08
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.