Z-0461-2021Class II

cobas infinity central lab/cobas infinity core license-The cobas infinity IT solutions application is...

Name: Z-0461-2021 cobas infinity central lab/cobas infinity core license-The cobas infinity IT solutions application is...
Creator: Roche Diagnostics Operations, Inc.
Published: 2020-10-09
License: https://open.fda.gov/license/

Roche Diagnostics GmbH / initiated 2020-10-09 / Terminated / root cause: software

FDA source

Roche Diagnostics Operations, Inc. began a recall of cobas infinity central lab/cobas infinity core license-The cobas infinity IT solutions application is intended to be used for the configuration and... on 2020-10-09. FDA classified it as Class II and gives the reason as "Potential Incorrect Validation of Results Due to an Erroneous QC Status When Using Status Expiration Control Rule". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-0461-2021
Classification: Class II
Status: Terminated
Initiated: 2020-10-09
Posted: 2020-11-17
Terminated: 2023-06-09
Recalling firm: Roche Diagnostics GmbH
Product: 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 code: JQP Calculator/Data Processing Module, For Clinical Use
Reason for recall: Potential Incorrect Validation of Results Due to an Erroneous QC Status When Using Status Expiration Control Rule
Root cause tag: software
FDA root cause: Software design
Action: Roche issued Urgent Medical Device Correction TP-01100 is on 10/9/20 via UPS Ground (receipt signature required). Letter states reason for recall, health risk and action to take: Until cobas infinity Service Patches are available and implemented at your site, follow the containment measures outlined in the Applying Containment Measures section of this UMDC. " If you run the QC module in the cobas infinity application, contact the Roche Support Network Customer Support Center at 1-800-526-2272, and a representative will run a script to help you determine if your facility might be impacted. " Please consult with the physician or pathologist at your facility to determine specific clinical implications for your patients. " Complete the attached faxback form (TP-01111) and fax or email it according to the instructions on the form. " File this Urgent Medical Device Correction (UMDC) for future reference. The cobas infinity Service Patches 3.01.12 (to correct affected versions 3.01.xx) and 3.02.05 (to correct affected versions 3.02.xx) are planned to be available in the fourth quarter of 2020. Once the Services Patches are available, a Roche Diagnostics representative will contact you to coordinate the corresponding installation.
Quantity in commerce: 40 licenses
Distribution: Nationwide
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0461-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0461-2021	Class II	Terminated	Voluntary: Firm initiated	2020-11-25	2020-11-17

Product code JQP

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)