Z-0267-05

DL2000 Data Manager Software, Version 6.4.108

Name: Z-0267-05 DL2000 Data Manager Software, Version 6.4.108
Creator: Beckman Coulter Inc
Published: 2004-11-05
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2004-11-05 / Terminated / root cause: software

FDA source

Beckman Coulter Inc began a recall of DL2000 Data Manager Software, Version 6.4.108 on 2004-11-05. The reason FDA records is "Possibility of reporting an incorrect result occurs due to a software anomally". 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-0267-05
Status: Terminated
Initiated: 2004-11-05
Posted: 2004-11-30
Terminated: 2005-03-16
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: DL2000 Data Manager Software, Version 6.4.108
Product code: JQP Calculator/Data Processing Module, For Clinical Use
Reason for recall: Possibility of reporting an incorrect result occurs due to a software anomally.
Root cause tag: software
FDA root cause: Other
Action: Letters were sent to sites on November 5, 2004 to confirm previous telephone conversations with the consignees.
Quantity in commerce: 3
Distribution: Product was under evaluation at three sites in FL, IL, and CA.
Product codes and lots: Version 6.4.108

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)