Z-1022-04

Tecan Clinical Workstations with Robonet software

Name: Z-1022-04 Tecan Clinical Workstations with Robonet software
Creator: Tecan U S Inc
Published: 2004-05-03
License: https://open.fda.gov/license/

Tecan U.S. / initiated 2004-05-03 / Terminated / root cause: software

FDA source

Tecan U S Inc began a recall of Tecan Clinical Workstations with Robonet software on 2004-05-03. The reason FDA records is "Tecan software has the potential to match the patient with a different patient's test 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-1022-04
Status: Terminated
Initiated: 2004-05-03
Posted: 2004-07-20
Terminated: 2005-05-17
Recalling firm: Tecan U.S.
Product: Tecan Clinical Workstations with Robonet software
Product code: JQW Station, Pipetting And Diluting, For Clinical Use
Reason for recall: Tecan software has the potential to match the patient with a different patient's test results.
Root cause tag: software
FDA root cause: Other
Action: Consignees were notified by letter on May 3, 2004
Quantity in commerce: 44 units (hardware), 33 units (software)
Distribution: CA, CT, GA, IL, IN, MA, MD, MI, NJ, NY, PA, TN, TX, VA, & WI.
Product codes and lots: PN 10-410 Tecan Genesis 150/8 Back End Configuration, PN 10-415 Tecan Genesis 150/8 Front End Configuration, PN 10-309 Tecan Genesis 200/8 Workstation, PN 10-307 Tecan Genesis 150/8 Workstation, PN 10-043A Tecan Genesis RSP 150/8, PN 10-040A Tecan Genesis RSP 100/4, PN 10-401A Tecan Genesis RSP 100/8,

Product code JQW

K953345Class IGenesisTecan U.S., Inc. / cleared 1995-11-21

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)