Z-1440-05

Aqueduct Hematology Workflow Manager, software

Name: Z-1440-05 Aqueduct Hematology Workflow Manager, software
Creator: Beckman Coulter Inc
Published: 2005-08-10
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2005-08-10 / Terminated / root cause: software

FDA source

Beckman Coulter Inc began a recall of Aqueduct Hematology Workflow Manager, software on 2005-08-10. The reason FDA records is "Potentail for misidentification of historical patient results within the Aqueduct Hematology Workflow Manager software. In instances where the workflow manager software receives the same patient identifier for more than...". 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-1440-05
Status: Terminated
Initiated: 2005-08-10
Posted: 2015-06-25
Terminated: 2012-04-03
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: Aqueduct Hematology Workflow Manager, software
Product code: JQP Calculator/Data Processing Module, For Clinical Use
Reason for recall: Potentail for misidentification of historical patient results within the Aqueduct Hematology Workflow Manager software. In instances where the workflow manager software receives the same patient identifier for more than one patient the Aqueduct Workflow Manager software merges all results into one Patient File. The may cause test results to be associated with the wrong patient.
Root cause tag: software
FDA root cause: Other
Action: A Product corrective action letter to be mailed the week of August 8, 2005, to all customers directing that each patient is identified with a truly unique patient identifier.
Quantity in commerce: 36
Distribution: AK, AZ, CA, DE, FL, IN, KS, MA, MI, MN, MO, NC, NY, OH, PA, TX, VA, WA
Product codes and lots: Part Number AQDCT

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)