Z-0997-04

Tecan clinical workstation; Tecan Genesis 150/8 TCW front end COBAS (FEC), Roche catalog number 0360053001

Name: Z-0997-04 Tecan clinical workstation; Tecan Genesis 150/8 TCW front end COBAS (FEC), Roche catalog number 0360053001
Creator: Roche Diagnostics Corp.
Published: 2004-03-05
License: https://open.fda.gov/license/

Roche Diagnostics GmbH / initiated 2004-03-05 / Terminated

FDA source

Roche Diagnostics Corp. began a recall of Tecan clinical workstation; Tecan Genesis 150/8 TCW front end COBAS (FEC), Roche catalog number 0360053001 on 2004-03-05. The reason FDA records is "If the files are not periodically purged from the TCW computer, it may result in patient identification/sample results mismatches". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0997-04
Status: Terminated
Initiated: 2004-03-05
Posted: 2004-07-20
Terminated: 2007-08-07
Recalling firm: Roche Diagnostics GmbH
Product: Tecan clinical workstation; Tecan Genesis 150/8 TCW front end COBAS (FEC), Roche catalog number 0360053001.
Product code: JQW Station, Pipetting And Diluting, For Clinical Use
Reason for recall: If the files are not periodically purged from the TCW computer, it may result in patient identification/sample results mismatches.
FDA root cause: Other
Action: Roche sent each of their consignees revised Tecan database maintenance instruction via bulletin 04-042 dated 3/5/04.
Quantity in commerce: 8
Distribution: Nationwide. California, Connecticut, Georgia, Illinois, Indiana, Maryland, Massachusetts, Michigan, New Jersey, North Carolina, Ohio, Pennsylvania, Tennessee, Texas and Wisconsin.
Product codes and lots: Serial numbers 6178, 7629, 7698, 7744, 7753, 7754, 7755 and 7768.

Product code JQW

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)