Roche Diagnostics Operations, Inc.: Medical Device Recall in 2020 - (Recall #: Z-0461-2021)

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-The cobas infinity IT solutions application is intended to be used for the configuration and connectivity management of instruments and software systems Catalog Number: 07154003001

Product Classification:

Class II

Date Initiated: October 9, 2020

Date Posted: November 25, 2020

Recall Number: Z-0461-2021

Event ID: 86609

Reason for Recall:

Potential Incorrect Validation of Results Due to an Erroneous QC Status When Using Status Expiration Control Rule

Status: Terminated

Product Quantity: 40 licenses

Code Information:

Software versions from cobas infinity version 3.00.00 onwards Serial Numbers: 82014 82229 82028 82227 82066 81967 81946 82121 82027 82194 82120 81528 82231 81958 82246 81983 82118 82165 81886 82082 82256 82257 81781 82331 82304 82087 82276 81465 81959 82235 82180 82181 82236 81945 82275 81662 82065 82253 81817 82000

Distribution Pattern:

Nationwide

Voluntary or Mandated:

Voluntary: Firm initiated