Z-1027-04

DL 2000 Data Manager, Software Version 6.2

Name: Z-1027-04 DL 2000 Data Manager, Software Version 6.2
Creator: Beckman Coulter Inc
Published: 2004-02-14
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2004-02-14 / Terminated / root cause: software

FDA source

Beckman Coulter Inc began a recall of DL 2000 Data Manager, Software Version 6.2 on 2004-02-14. The reason FDA records is "Software defect. The type of results affected were replicate type results for a single sample transmitted within the same data stream". 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-1027-04
Status: Terminated
Initiated: 2004-02-14
Posted: 2004-07-20
Terminated: 2004-12-02
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: DL 2000 Data Manager, Software Version 6.2
Reason for recall: Software defect. The type of results affected were replicate type results for a single sample transmitted within the same data stream.
Root cause tag: software
FDA root cause: Other
Action: Recall is complete. Letters were mailed to customers on 2/14/2003. Instruments received upated software version 6.3.
Quantity in commerce: 231
Distribution: Nationwide.
Product codes and lots: Version 6.2

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)