Roche Diagnostics Operations, Inc.: Medical Device Recall in 2021 - (Recall #: Z-2444-2021)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2021.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: June 24, 2021

Date Posted: September 22, 2021

Recall Number: Z-2444-2021

Event ID: 88398

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.

Status: Terminated

Product Quantity: 2058 licenses worldwide, 79 licenses in US

Code Information:

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

Distribution Pattern:

US Nationwide distribution

Voluntary or Mandated:

Voluntary: Firm initiated