Z-1394-2009

Roche cobas 6000 analyzer series (including cobas c 501 and cobas e 601 modules) Middleware Solutions...

Name: Z-1394-2009 Roche cobas 6000 analyzer series (including cobas c 501 and cobas e 601 modules) Middleware Solutions...
Creator: Roche Diagnostics Corp.
Published: 2009-04-01
License: https://open.fda.gov/license/

Roche Diagnostics GmbH / initiated 2009-04-01 / Terminated / root cause: design

FDA source

Roche Diagnostics Corp. began a recall of Roche cobas 6000 analyzer series (including cobas c 501 and cobas e 601 modules) Middleware Solutions Instrument Manager Server as follows: v.8.04.02.10... on 2009-04-01. The reason FDA records is "Some data alarm flags do not transfer from the analyzer to the laboratory information system, since not all data flags are recognized by the instrument manager/middleware". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1394-2009
Status: Terminated
Initiated: 2009-04-01
Posted: 2009-05-20
Terminated: 2009-12-07
Recalling firm: Roche Diagnostics GmbH
Product: Roche cobas 6000 analyzer series (including cobas c 501 and cobas e 601 modules) Middleware Solutions Instrument Manager Server as follows: v.8.04.02.10, catalog no. 04785568001; v.8.04.03.01, catalog no. 04785568002; and v.8.06.02, catalog no. 05109019001. The device is used to interface hospital LIS systems with Roche c 6000 analyzers and allows order and result communication to occur between the two systems.
Product code: JQP Calculator/Data Processing Module, For Clinical Use
Reason for recall: Some data alarm flags do not transfer from the analyzer to the laboratory information system, since not all data flags are recognized by the instrument manager/middleware.
Root cause tag: design
FDA root cause: Component design/selection
Action: Consignees were notified by "Urgent Medical Device Correction" letter dated April 1, 2009 and instructed to add error codes to the Instrument Manager driver and to contact the manufacturer of their LIS for instructions on adding data alarm codes to the LIS. Consignees were also instructed to complete the attached fax form after adding the error codes to their system and fax to 1-888-345-4690. Contact Roche Diagnostics Technical Support at 1-800-428-2336 for questions about information contained in the notification letter.
Quantity in commerce: 498 of all products.
Distribution: Nationwide Distribution.
Product codes and lots: All units.

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)