Z-0869-03

Tecan Genesis RSP and NPS Instruments with barcode scanner type PosID2 option with firmware version 2.45 or...

Name: Z-0869-03 Tecan Genesis RSP and NPS Instruments with barcode scanner type PosID2 option with firmware version 2.45 or...
Creator: Tecan U S Inc
Published: 2003-02-27
License: https://open.fda.gov/license/

Tecan U.S. / initiated 2003-02-27 / Terminated / root cause: labeling and UDI

FDA source

Tecan U S Inc began a recall of Tecan Genesis RSP and NPS Instruments with barcode scanner type PosID2 option with firmware version 2.45 or lower on 2003-02-27. The reason FDA records is "Firmware defect. Under certain conditions a strip rack is no longer in the initial position after a motor overload of the barcode scanner PosID2". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0869-03
Status: Terminated
Initiated: 2003-02-27
Posted: 2003-05-29
Terminated: 2006-04-06
Recalling firm: Tecan U.S.
Product: Tecan Genesis RSP and NPS Instruments with barcode scanner type PosID2 option with firmware version 2.45 or lower.
Product code: JQW Station, Pipetting And Diluting, For Clinical Use
Reason for recall: Firmware defect. Under certain conditions a strip rack is no longer in the initial position after a motor overload of the barcode scanner PosID2.
Root cause tag: labeling and UDI
FDA root cause: Other
Action: Tecan US notified consignees by registered letter on/about 3/13/2003. International accounts were notified via e-mail 3/13/2003 by Tecan Switzerland. Consignees were advised to contact the firm''s Technical Support line to coordinate the PosID firmware upgrade.
Quantity in commerce: 327 instruments require firmware upgrade.
Distribution: Instruments requiring upgrade were distributed to various clinical laboratories and blood banks Nationwide and World wide .
Product codes and lots: Genesis 100, 150 &200, Tecan PosID2 units with firmware version 2.5 or lower

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)