FDA Medical Device Recalls (openFDA)
Beckman Coulter Inc: Aqueduct Hematology Workflow Manager, software
- Recall number
- Z-1440-05
- Recalling firm
- Beckman Coulter Inc
- Product
- Aqueduct Hematology Workflow Manager, software
- Status
- Terminated
- Initiated
- 2005-08-10
- Posted
- not on file
- Terminated
- 2012-04-03
- Reason
- 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
- 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
- 36
- Distribution
- AK, AZ, CA, DE, FL, IN, KS, MA, MI, MN, MO, NC, NY, OH, PA, TX, VA, WA
- Lot, serial or model codes
- Part Number AQDCT
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- JQP
- Firm FEI
- 2050012
- Firm city
- Brea
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28