Z-0224-2007

Roche Cobas driver (rchcob6i), analytical laboratory data interface

Name: Z-0224-2007 Roche Cobas driver (rchcob6i), analytical laboratory data interface
Creator: Data Innovations, Inc.
Published: 2006-11-03
License: https://open.fda.gov/license/

Data Innovations, LLC / initiated 2006-11-03 / Terminated / root cause: software

FDA source

Data Innovations, Inc. began a recall of Roche Cobas driver (rchcob6i), analytical laboratory data interface on 2006-11-03. The reason FDA records is "Software of modular driver may incorrectly report patient results as Quality Control Results". 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-0224-2007
Status: Terminated
Initiated: 2006-11-03
Posted: 2006-11-29
Terminated: 2015-06-11
Recalling firm: Data Innovations, LLC
Product: Roche Cobas driver (rchcob6i), analytical laboratory data interface.
Product code: JQP Calculator/Data Processing Module, For Clinical Use
Reason for recall: Software of modular driver may incorrectly report patient results as Quality Control Results
Root cause tag: software
FDA root cause: Software change control
Action: Data Innovations notified users by email listserv and by letter dated 10/25/06.
Quantity in commerce: 56
Distribution: Nationwide and Canada.
Product codes and lots: Software version: v8.00.0001 and v7.00.0001

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)