Roche Diagnostics Operations, Inc.: Medical Device Recall in 2020 - (Recall #: Z-1158-2020)

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 core, Material No. 7154003001. The device is a calculator/data processing module, for clinical use.

Product Classification:

Class II

Date Initiated: January 7, 2020

Date Posted: February 19, 2020

Recall Number: Z-1158-2020

Event ID: 84697

Reason for Recall:

Alarm flags that have a "<" symbol in front of them are not displayed on the cobas infinity Validation screen. This issue affects only customers that are doing manual validation on the cobas infinity Validation screen.

Status: Terminated

Product Quantity: 26 accounts

Code Information:

All cobas infinity laboratory solution software versions are affected.

Distribution Pattern:

Distributed to customers in AK, AL, CA, GA, HI, IA, IL, KY, MA, MI, MN, MO, MS, MT, NJ, NY, OR, SC, and TN.

Voluntary or Mandated:

Voluntary: Firm initiated