Roche Diagnostics Operations, Inc.: Medical Device Recall in 2020 - (Recall #: Z-0922-2020)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2020.

Data Source: FDA.

Product Description:

Cobas infinity central lab / cobas infinity core license-a Calculator/Data Processing Module, For Clinical Use Material Number: 07154003001

Product Classification:

Class II

Date Initiated: October 8, 2019

Date Posted: February 5, 2020

Recall Number: Z-0922-2020

Event ID: 84128

Reason for Recall:

Cobasinfinity laboratory solution Version 2.4.1 through Version 2.5.4 Using a CommServer Driver - Incorrect Alarm Mapping

Status: Terminated

Product Quantity: 20

Code Information:

Cobas infinity software version 2.4.1 through 2.5.4

Distribution Pattern:

US Nationwide in the states of AL, CA, GA, IA, IL, KY, MI, MO, MT, NJ, NY, OR, TN

Voluntary or Mandated:

Voluntary: Firm initiated