Z-0805-03

COULTER PrepPlus and PrepPlus 2, Pipetting and Diluting station for Clinical Use

Name: Z-0805-03 COULTER PrepPlus and PrepPlus 2, Pipetting and Diluting station for Clinical Use
Creator: Beckman Coulter Inc
Published: 2003-03-28
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2003-03-28 / Terminated / root cause: software

FDA source

Beckman Coulter Inc began a recall of COULTER PrepPlus and PrepPlus 2, Pipetting and Diluting station for Clinical Use on 2003-03-28. The reason FDA records is "Software problem may cause the instrument to skip the probe-wash step before processing different reagents". 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-0805-03
Status: Terminated
Initiated: 2003-03-28
Posted: 2003-05-09
Terminated: 2003-10-14
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: COULTER PrepPlus and PrepPlus 2, Pipetting and Diluting station for Clinical Use
Product code: JQW Station, Pipetting And Diluting, For Clinical Use
Reason for recall: Software problem may cause the instrument to skip the probe-wash step before processing different reagents.
Root cause tag: software
FDA root cause: Other
Action: The firm sent notification letter and modified operating instructions by mail on March 28, 2003.
Quantity in commerce: 91
Distribution: USA and Canada
Product codes and lots: All existing versions of the software. Serial numbers PrepPlus 0006026440 and above PrepPlus 2 0109079674 and above

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)