Z-2444-2021Class II

cobas infinity central lab running software version 3.01.03 through 3.02.08, Catalog#: 07154003001

Name: Z-2444-2021 cobas infinity central lab running software version 3.01.03 through 3.02.08, Catalog#: 07154003001
Creator: Roche Diagnostics Operations, Inc.
Published: 2021-06-24
License: https://open.fda.gov/license/

Roche Diagnostics GmbH / initiated 2021-06-24 / Terminated / root cause: software

FDA source

Roche Diagnostics Operations, Inc. began a recall of cobas infinity central lab running software version 3.01.03 through 3.02.08, Catalog#: 07154003001 on 2021-06-24. FDA classified it as Class II and gives the reason as "Under specific circumstances created by the user, the cobas e flow test results could be replaced by an automatic result sent to the lab LIS. This automatic result could be released and interpreted by your Laboratory...". 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-2444-2021
Classification: Class II
Status: Terminated
Initiated: 2021-06-24
Posted: 2021-09-10
Terminated: 2023-07-21
Recalling firm: Roche Diagnostics GmbH
Product: cobas infinity central lab running software version 3.01.03 through 3.02.08, Catalog#: 07154003001
Product code: JQP Calculator/Data Processing Module, For Clinical Use
Reason for recall: Under specific circumstances created by the user, the cobas e flow test results could be replaced by an automatic result sent to the lab LIS. This automatic result could be released and interpreted by your Laboratory Information System (LIS) as a false positive or negative result. It should be noted that the "correct" result would still be available on the instrument.
Root cause tag: software
FDA root cause: Software design
Action: An Urgent Medical Device Correction notification letter dated 6/24/21 was sent to customers. Actions Required " Follow the Workaround section of this Urgent Medical Device Correction (UMDC), if applicable. " Consult with the physician or pathologist at your facility to determine any clinical implications specific to your patients. " Until the service patch is available, use the workaround described in this UMDC. " Complete all sections of the enclosed faxback form (TP-01337) and fax it to 1-847-457-1389 or email it to [email protected]. " File this UMDC for future reference. Identifying the Issue This issue occurs under specific circumstances and ALL of the conditions listed in the Issue section on page one of this UMDC must be fulfilled in order for the issue to occur. The issue can be identified when: " the current result appears as a repetition in the validation screen, " the Raw result column will appear blank indicating that the current result was not received from the instrument, and " the test alarm REP is triggered that indicates that the test results were repeated. Also, the issue can be detected in the validation screen based on the information that might be shown. The list below may help identify the issue (depending on your system configuration): " The LIS test result differs from the analyzer result. " There is a test alarm indicating the result is a repetition. " There is no analyzer associated with the result. " The main result time differs from some or all of the embedded result times. " The Preliminary result column displays the previous result, which corresponds to the original result sent by the instrument. " The repetition icon indicates the number of repetitions (i.e., 1 or more). Workaround Roche recommends contacting the Roche Support Network Customer Support Center at 1-800-526-2272 to request support for the workaround listed below: The following workaround can be used until the service patches are available to resolve this i
Quantity in commerce: 2058 licenses worldwide, 79 licenses in US
Distribution: US Nationwide distribution
Product codes and lots: UDI: 04015630936007; All systems running software version 3.01.03 - 3.02.08

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2444-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2444-2021	Class II	Terminated	Voluntary: Firm initiated	2021-09-22	2021-09-10

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)