Z-1158-2020Class II

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

Name: Z-1158-2020 cobas infinity core, Material No. 7154003001. The device is a calculator/data processing module, for clinical...
Creator: Roche Diagnostics Operations, Inc.
Published: 2020-01-07
License: https://open.fda.gov/license/

Roche Diagnostics GmbH / initiated 2020-01-07 / Terminated

FDA source

Roche Diagnostics Operations, Inc. began a recall of cobas infinity core, Material No. 7154003001. The device is a calculator/data processing module, for clinical use on 2020-01-07. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1158-2020
Classification: Class II
Status: Terminated
Initiated: 2020-01-07
Posted: 2020-02-12
Terminated: 2020-10-15
Recalling firm: Roche Diagnostics GmbH
Product: cobas infinity core, Material No. 7154003001. The device is a calculator/data processing module, for clinical use.
Product code: JQP Calculator/Data Processing Module, For Clinical Use
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.
FDA root cause: Under Investigation by firm
Action: On 1/7/2020, the firm distributed Urgent Medical Device Correction letters to affected consignees. Customers were asked to do the following: " Be aware of the incorrect display of the alarm flags on the cobas infinity Validation screen if an alarm has a < symbol in front of it and if doing manual validations. " It is not recommended to use the alarm mapping function on the cobas infinity until your system is patched. If your laboratory does use it, please call the Roche Support Network Customer Support Center at 1-800-526-2272 for further information. " Complete the customer response form and return it to the recalling firm. Please 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 about the information contained in this UMDC.
Quantity in commerce: 26 accounts
Distribution: Distributed to customers in AK, AL, CA, GA, HI, IA, IL, KY, MA, MI, MN, MO, MS, MT, NJ, NY, OR, SC, and TN.
Product codes and lots: All cobas infinity laboratory solution software versions are affected.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1158-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1158-2020	Class II	Terminated	Voluntary: Firm initiated	2020-02-19	2020-02-12

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)