Z-0922-2020Class II

Cobas infinity central lab / cobas infinity core license-a Calculator/Data Processing Module, For Clinical...

Name: Z-0922-2020 Cobas infinity central lab / cobas infinity core license-a Calculator/Data Processing Module, For Clinical...
Creator: Roche Diagnostics Operations, Inc.
Published: 2019-10-08
License: https://open.fda.gov/license/

Roche Diagnostics GmbH / initiated 2019-10-08 / Terminated / root cause: software

FDA source

Roche Diagnostics Operations, Inc. began a recall of Cobas infinity central lab / cobas infinity core license-a Calculator/Data Processing Module, For Clinical Use Material Number: 07154003001 on 2019-10-08. FDA classified it as Class II and gives the reason as "Cobasinfinity laboratory solution Version 2.4.1 through Version 2.5.4 Using a CommServer Driver - Incorrect Alarm Mapping". 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-0922-2020
Classification: Class II
Status: Terminated
Initiated: 2019-10-08
Posted: 2020-01-30
Terminated: 2020-10-15
Recalling firm: Roche Diagnostics GmbH
Product: Cobas infinity central lab / cobas infinity core license-a Calculator/Data Processing Module, For Clinical Use Material Number: 07154003001
Product code: JQP Calculator/Data Processing Module, For Clinical Use
Reason for recall: Cobasinfinity laboratory solution Version 2.4.1 through Version 2.5.4 Using a CommServer Driver - Incorrect Alarm Mapping
Root cause tag: software
FDA root cause: Software design
Action: Roche issued Urgent Medical Device Correction TP-00791 mailed via UPS Ground (receipt required) on 10/8/2019. The letter identifies the problem, health risk and action to take: Complete the attached fax form (TP-00792) and fax or email it according to the instructions on the form. " File this Urgent Medical Device Correction (UMDC) for future reference Roche will resolve this issue in a future software update. In the next couple of weeks, a Roche Representative will be contacting you to adjust alarm code mapping as needed per your specific configuration. Contact the Roche Support Network Customer Support Center 24 hours a day, seven days a week at 1-800-526-2272 if you have questions. The UMDC will also post to the diagnostics.roche.com website
Quantity in commerce: 20
Distribution: US Nationwide in the states of AL, CA, GA, IA, IL, KY, MI, MO, MT, NJ, NY, OR, TN
Product codes and lots: Cobas infinity software version 2.4.1 through 2.5.4

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0922-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0922-2020	Class II	Terminated	Voluntary: Firm initiated	2020-02-05	2020-01-30

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)