Z-1372-05

DL 2000 Data Manager

Name: Z-1372-05 DL 2000 Data Manager
Creator: Beckman Coulter Inc
Published: 2005-06-20
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2005-06-20 / Terminated

FDA source

Beckman Coulter Inc began a recall of DL 2000 Data Manager on 2005-06-20. The reason FDA records is "Version v6.4.109f, any result designated as 'calculated chemistry' at DL2000 may upload to the LIS with an incorrect or blank sample ID". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1372-05
Status: Terminated
Initiated: 2005-06-20
Posted: 2005-08-16
Terminated: 2011-10-06
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: DL 2000 Data Manager
Product code: JQP Calculator/Data Processing Module, For Clinical Use
Reason for recall: Version v6.4.109f, any result designated as 'calculated chemistry' at DL2000 may upload to the LIS with an incorrect or blank sample ID.
FDA root cause: Other
Action: Recall letters were sent during the week of June 20, 2005. It explains the problem and indicates that an enclosed software correction must be installed to correct the problem.
Quantity in commerce: 287
Distribution: Nationwide.
Product codes and lots: Not Applicable but refers to software version 6.4.109f

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)