Z-0952-2023Class II

cobas infinity central lab, Material Number 07154003001

Name: Z-0952-2023 cobas infinity central lab, Material Number 07154003001
Creator: Roche Diagnostics Operations, Inc.
Published: 2022-12-12
License: https://open.fda.gov/license/

Roche Diagnostics GmbH / initiated 2022-12-12 / Open, Classified / root cause: software

FDA source

Roche Diagnostics Operations, Inc. began a recall of cobas infinity central lab, Material Number 07154003001 on 2022-12-12. FDA classified it as Class II and gives the reason as "A complaint investigation revealed that an incorrect behavior relating to the rejection of orders capability of the Host Connectivity Agent (HCA) could occur where the order received from the Laboratory Information...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as software.

Recall record

Recall number: Z-0952-2023
Classification: Class II
Status: Open, Classified
Initiated: 2022-12-12
Posted: 2023-01-12
Recalling firm: Roche Diagnostics GmbH
Product: cobas infinity central lab, Material Number 07154003001
Product code: JQP Calculator/Data Processing Module, For Clinical Use
Reason for recall: A complaint investigation revealed that an incorrect behavior relating to the rejection of orders capability of the Host Connectivity Agent (HCA) could occur where the order received from the Laboratory Information System (LIS) is created with an Internal ID rather than the External ID sent from the LIS. The erroneous event occurs under rare circumstances where the date in the sample's barcode does not match the order date sent from the LIS, and can lead to the order being mismatched to an another patient's sample ID rather than the subject patient's sample ID. The software bug impacts multiple cobas infinity central lab software (versions 2.5.x , 3.01.x, 3.02.x, and 3.03.x) and occurs when the afflicted software has been configured with specific pre-conditions.
Root cause tag: software
FDA root cause: Software design
Action: On December 12, 2022, the firm notified affected customers through Urgent Medical Device Correction letters. Customers were informed of the product issue. A Roche Diagnostics representative will contact you in the near future to assess your cobas infinity configuration and to determine if it meets all pre-conditions. If so, your Roche representative will work with you to implement a workaround immediately in addition to working with you to apply a more permanent solution via a software patch once available. Customers should consult with a physician or pathologist at your facility to determine clinical implications specific to your patients. 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 this recall.
Quantity in commerce: 224 US; 2,797 worldwide
Distribution: Domestic distribution nationwide. Foreign distribution pending.
Product codes and lots: cobas infinity central lab / cobas infinity core license using software versions (2.5.x , 3.01.x, 3.02.x, and 3.03.x) that have been configured with all of the following pre-conditions will be impacted: 1. Having Order ID configuration to include the date (Not Common in U.S. Configurations) 2. Having a host configured by Order rather than Tube (Not Common in U.S..Configurations) 3. Having message configured to receive registration date of the order using ExtRegisterDate and ExtRegisterHour. 4. Having HCA configuration enabled for " Reject orders if not possible to assign External ID" and the radio button option set to "To at least one test" UDI-DI 04015630936007

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0952-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0952-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-01-18	2023-01-12

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