Z-0883-2021Class II

A calculator/data processing module for clinical use is an electronic device intended to store, retrieve, and...

Name: Z-0883-2021 A calculator/data processing module for clinical use is an electronic device intended to store, retrieve, and...
Creator: Roche Diagnostics Operations, Inc.
Published: 2020-12-17
License: https://open.fda.gov/license/

Roche Diagnostics GmbH / initiated 2020-12-17 / Terminated / root cause: software

FDA source

Roche Diagnostics Operations, Inc. began a recall of A calculator/data processing module for clinical use is an electronic device intended to store, retrieve, and process laboratory data Catalog Number... on 2020-12-17. FDA classified it as Class II and gives the reason as "A software error results in the unintentional removal of the serum-indices flag that would otherwise prevent the release of results. The Cobas Inifinity has an auto-verification feature to hold results for manual review...". 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-0883-2021
Classification: Class II
Status: Terminated
Initiated: 2020-12-17
Posted: 2021-01-22
Terminated: 2023-05-19
Recalling firm: Roche Diagnostics GmbH
Product: A calculator/data processing module for clinical use is an electronic device intended to store, retrieve, and process laboratory data Catalog Number: 07154003001
Product code: JQP Calculator/Data Processing Module, For Clinical Use
Reason for recall: A software error results in the unintentional removal of the serum-indices flag that would otherwise prevent the release of results. The Cobas Inifinity has an auto-verification feature to hold results for manual review when they meet specific criteria. The serum indices flag is used for serum indices tests that are performed to assess the quality of the sample (e.g. hemolysis, icterus, and lipemia). Normally, when the Cobas Infinity receives a result for a test that is serum indices-sensitive, it flags the result and the software then waits for the results of the serum indices tests before validating or rejecting the test result. Roche has discovered a software error that under specific conditions causes the flag to be incorrectly removed. This allows for the possibility that a sample of poor quality may return an unreliable/incorrect test result that is mistakenly reported to the health care provider and/or patient without the proper disclaimer that the result is based on a sample of poor quality.
Root cause tag: software
FDA root cause: Software design
Action: Roche issued Urgent Medical Device Correction, (UMDC TP-01176) via UPS Ground (receipt required) on 12/17/20. The UMDC TP-01176 will also post to the diagnostics.roche.com website. Letter states reason for recall, health risk and action to take: Complete the enclosed faxback form, TP-01177, and return it following the instructions on the form even if you are not using the Cross SI option. " If you are using the Cross SI option, refer to the Workarounds section of this Urgent Medical Device Correction (UMDC) until the Service Patch for your cobas infinity central lab is available for this issue. " File this UMDC for future reference 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: 76 licenses
Distribution: US Nationwide
Product codes and lots: All versions from cobas infinity version 3.00.00 onwards

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0883-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0883-2021	Class II	Terminated	Voluntary: Firm initiated	2021-01-27	2021-01-21

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)